Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
30 juin 2015 mis à jour par: Veloxis Pharmaceuticals
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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San Diego, California, États-Unis, 92123
- Clinical Investigative Site 000015
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San Francisco, California, États-Unis, 94115
- Clinical Investigative Site 000012
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Clinical Investigative Site 00004
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Florida
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Tampa, Florida, États-Unis, 33606
- Clinical Investigative Site 000002
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Kentucky
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Lexington, Kentucky, États-Unis, 40536-0293
- Clinical Investigative Site 000005
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Clinical Investigative Site 000009
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New Jersey
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Livingston, New Jersey, États-Unis, 07039
- Clinical Investigative Site 000010
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New York
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Buffalo, New York, États-Unis, 14215
- Clinical Investigative Site 000011
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New York, New York, États-Unis, 10016
- Clinical Investigative Site 00006
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Ohio
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Cleveland, Ohio, États-Unis, 44095
- Clinical Investigative Site 00008
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Clinical Investigative Site 00003
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Texas
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Dallas, Texas, États-Unis, 75246
- Clinical Investigative Site 000013
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Virginia
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Charlottesville, Virginia, États-Unis, 22903
- Clinical Investigative Site 00001
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion criteria
- Give written consent
- Male and female subjects between the ages of 18 and 70 years, inclusive
- Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
- WOCBP must have a negative pregnancy test
- Must have negative cross-match test and be ABO-compatible
- Must be able to swallow tablets and capsules
Exclusion criteria
- Recipients of any previous nonrenal or concurrent transplant
- Have panel reactive antibody >50%
- Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
- History of alcohol abuse with less than 6 months of sobriety
- History of recreational drug abuse with less than 6 months of documented abstinence
- Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
- WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
- Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
- Oral temperature (prior to study drug dosing) of 38.0ºC or higher
- CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
- Known hereditary immunodeficiency
- Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
- Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Clinically symptomatic CHF or documented EJF of less than 45%
- Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
- Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
- Laboratory variables that are abnormal (outside laboratory reference range) and CS
- Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
- Subjects who have had primary focal segmental glomerulosclerosis
- Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
Autres noms:
|
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Comparateur actif: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
|
Tacrolimus
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 1 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
|
1 days
|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 14 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
|
14 days
|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 28 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
|
28 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 1 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
|
1 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 14 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 28 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 1 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
|
1 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 14 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 28 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 14 days
|
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Délai: 28 days
|
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Délai: 14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Délai: 28 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
|
28 days
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
Délai: 14 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
|
14 days
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
Délai: 28 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
|
28 days
|
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Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
Délai: 30 days
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The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
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30 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: William Polvino, MD, Veloxis Pharmaceuticals
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2012
Achèvement primaire (Réel)
1 mars 2013
Achèvement de l'étude (Réel)
1 mai 2013
Dates d'inscription aux études
Première soumission
14 août 2012
Première soumission répondant aux critères de contrôle qualité
14 août 2012
Première publication (Estimation)
16 août 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 juillet 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juin 2015
Dernière vérification
1 juin 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCP-Tacro 2019
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