Summary
EudraCT Number:2019-004183-21
Sponsor's Protocol Code Number:IP-001-18
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-03-14
Trial results
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2019-004183-21
A.3Full title of the trial
A Study to Evaluate the EffIcacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis
Eine Studie zur Beurteilung der Wirksamkeit und Sicherheit von XyloCore,
einer glukosesparenden experimentellen Lösung für die Peritonealdialyse
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Study to Evaluate the EffIcacy and Safety of XyloCore, a low-glucose solution for peritoneal dialysis
Eine Studie zur Beurteilung der Wirksamkeit und Sicherheit von XyloCore,
einer glukosesparenden experimentellen Lösung für die Peritonealdialyse
A.3.2Name or abbreviated title of the trial where available
ELIXIR
A.4.1Sponsor's protocol code numberIP-001-18
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorIperboreal Pharma Srl
B.1.3.4CountryItaly
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportIperboreal Pharma Srl
B.4.2CountryItaly
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationIperboreal Pharma Srl
B.5.2Functional name of contact pointArduino Arduini
B.5.3 Address:
B.5.3.1Street AddressVia Piave n° 110/7
B.5.3.2Town/ cityPescara
B.5.3.3Post code65122
B.5.3.4CountryItaly
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameXylocore Low Strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNXylitol
D.3.9.1CAS number 87-99-0
D.3.9.4EV Substance CodeSUB15737MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number46
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INND-Glucose
D.3.9.1CAS number 14431-43-7
D.3.9.3Other descriptive nameD-GLUCOSE
D.3.9.4EV Substance CodeSUB74890
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number27.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNL-carnitine
D.3.9.1CAS number 541-15-1
D.3.9.3Other descriptive namelavocarnitine
D.3.9.4EV Substance CodeSUB08466MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1.24
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameXylocore Medium Strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNXylitol
D.3.9.1CAS number 87-99-0
D.3.9.4EV Substance CodeSUB15737MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number98.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INND-Glucose
D.3.9.1CAS number 14431-43-7
D.3.9.3Other descriptive nameD-GLUCOSE
D.3.9.4EV Substance CodeSUB74890
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number27.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNL-carnitine
D.3.9.1CAS number 541-15-1
D.3.9.3Other descriptive namelavocarnitine
D.3.9.4EV Substance CodeSUB08466MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1.24
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameXylocore High Strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNXylitol
D.3.9.1CAS number 87-99-0
D.3.9.4EV Substance CodeSUB15737MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INND-Glucose
D.3.9.1CAS number 14431-43-7
D.3.9.3Other descriptive nameD-GLUCOSE
D.3.9.4EV Substance CodeSUB74890
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number83
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNL-carnitine
D.3.9.1CAS number 541-15-1
D.3.9.3Other descriptive namelavocarnitine
D.3.9.4EV Substance CodeSUB08466MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1.24
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 4
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Physioneal 35 or 40 - Low strength
D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namePhysioneal 35 or 40 - low strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number75.5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 5
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Physioneal 35 or 40 - Medium strength
D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namePhysioneal 35 or 40 - Medium strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number126
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 6
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Physioneal 35 or 40 - High strength
D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namePhysioneal 35 or 40 - High strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number214
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 7
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Dianeal - Low strength
D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDianeal - Low strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number75.5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 8
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Dianeal - Medium strength
D.2.1.1.2Name of the Marketing Authorisation holder42338.01.00
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDianeal - Medium strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number126
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 9
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Dianeal - High strength
D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDianeal - High strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number214
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 10
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Balance - Low strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBalance - Low strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number83
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 11
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Balance - Medium strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBalance - Medium strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number126
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 12
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Balance - High strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBalance - High strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number235
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 13
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bicavera - Low strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBicavera - Low strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number83
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 14
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bicavera - Medium strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBicavera - Medium strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number126
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 15
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bicavera Forte (Bicanova) - Low strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBicavera Forte (Bicanova) - Low strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number83
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 16
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bicavera Forte (Bicanova) - medium strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBicavera Forte (Bicanova) - medium strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number126
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 17
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bicavera Forte (Bicanova) - high strength
D.2.1.1.2Name of the Marketing Authorisation holderFresenius Medical Care Deutschland GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBicavera Forte (Bicanova) - high strength
D.3.4Pharmaceutical form Solution for peritoneal dialysis
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlucose
D.3.9.1CAS number 50997
D.3.9.3Other descriptive nameGLUCOSE
D.3.9.4EV Substance CodeSUB13981MIG
D.3.10 Strength
D.3.10.1Concentration unit mmol/l millimole(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number235
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
End-Stage Renal Disease (ESRD)
E.1.1.1Medical condition in easily understood language
End-Stage Renal Disease (ESRD)
E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level PT
E.1.2Classification code 10077512
E.1.2Term End stage renal disease
E.1.2System Organ Class 10038359 - Renal and urinary disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective of this study is to demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/Vurea.
E.2.2Secondary objectives of the trial
-Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin) and insulin;
-Changes from the baseline values of hemoglobin and EPO requirements;
-Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, see Appendix 2)
-Peritoneal Ultrafiltration
-Blood pressure
-Diuresis
-Residual kidney function
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Patients who meet all of the following criteria will be enrolled:
1.Age ≥ 18 years
2.Diagnosed of ESRD and treated with CAPD in the last 3 months
3.In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
4.Have not experienced peritonitis episodes in the last 3 months
5.In treatment with Extraneal (nocturnal long-dwell exchange for at least one month);
6.In treatment with 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
7.Weekly Kt/V urea measurement > 1.7
8.Followed-up/treated by the participating clinical Center/Investigator in the last three months
9.Understanding the nature of the study and providing informed consent to participate in the study.
E.4Principal exclusion criteria
Patients who fulfill any of the following criteria will not be enrolled:
1.History of drug or alcohol abuse in the six months prior to entering the protocol
2.In treatment with androgens
3.Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
4.Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)
5.Expected patient’s survival shorter than trial duration
6.L-Carnitine therapy in the month prior to entering the protocol
7.Have used any investigational drug in the 3 months prior to entering the protocol
8.Female patients who are pregnant or breast-feeding.
9.Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception*
10.Patients affected by Primary Hyperoxaluria as per known medical hystory
11.Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
12.Patients with a major cardiovascular event in the last 3 months
13.Patients with advanced cardiac failure (NYHA 4).
14. Hypersensitivity to any of the constituents of the study IMPs.
15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.
16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
17. History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator.

E.5 End points
E.5.1Primary end point(s)
The primary outcome measure is total weekly Kt/Vurea after a 24-week period using the assigned PD solution, assessed using a peritoneal function test.
E.5.1.1Timepoint(s) of evaluation of this end point
6 months
E.5.2Secondary end point(s)
-Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin;
-Changes from the baseline values of hemoglobin and EPO requirements;
-Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, Appendix 2)
-Peritoneal Ultrafiltration
-Diuresis (or 24 hours urinary volume)
-Residual kidney function [measured as the arithmetic mean of urinary urea and creatinine clearance], Appendix 4 (Steubl 2019)
E.5.2.1Timepoint(s) of evaluation of this end point
6 months
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
blinded end-point assessment
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA42
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Denmark
Germany
Israel
Italy
Spain
Sweden
United Kingdom
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months6
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 85
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 85
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state15
F.4.2 For a multinational trial
F.4.2.1In the EEA 150
F.4.2.2In the whole clinical trial 170
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-08-19
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-05-06
P. End of Trial
P.End of Trial StatusOngoing