- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479088
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
Twelve-month, Multicenter, Intra-subject Controlled (Retrospective-prospective), Open-label, Active-treatment Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Cinacalcet Hydrochloride for the Treatment of Secondary Hyperparathyroidism (SHPT) in Paediatric Subjects With Chronic Kidney Disease (CKD) on Dialysis, Followed by 12-month Study Extension.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Enrico E. Verrina, MD
- Phone Number: +390105636276
- Email: enricoverrina@ospedale-gaslini.ge.it
Study Contact Backup
- Name: Ornella Della Casa Alberighi, MD PhD
- Phone Number: +390105636461
- Email: ornelladellacasa@ospedale-gaslini.ge.it
Study Locations
-
-
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Bari, Italy, 70100
- Active, not recruiting
- U.O. Nefrologia e Dialisi- Ospedale Giovanni XXIII
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Genoa, Italy, 16147
- Recruiting
- U.O. Nefrologia e Dialisi - Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini
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Contact:
- Ornella Della Casa Alberighi, MD PhD
- Phone Number: +390105636461
- Email: ornelladellacasa@ospedale-gaslini.ge.it
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Contact:
- Enrico E Verrina, MD
- Phone Number: +390105636276
- Email: enricoverrina@ospedale-gaslini.ge.it
-
Principal Investigator:
- Enrico E. Verrina, MD
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Milan, Italy, 20100
- Active, not recruiting
- U.O. Nefrologia e Dialisi Pediatrica - Clinica De Marchi
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Naples, Italy, 80100
- Active, not recruiting
- U.O. Nefrologia e Dialisi - Ospedale Santobono
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Rome, Italy, 00100
- Active, not recruiting
- U.O. Nefrologia e Dialisi - Ospedale Bambino Gesù
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents'/guardian written informed consent, and child's assent
- Age > 2 and <18 years;
- A dry body weight (BW) >10.49 Kg in males and >9.95 Kg in females, respectively;
- Inpatient or outpatient status at the time of enrolment;
- Males or females. Female subjects sexually active must be neither pregnant nor breastfeeding, and must lack childbearing potential from screening visit to the end of the safety follow-up
- On stable hemodialysis (HD) or peritoneal dialysis (PD) for their CKD for at least one month before entering the 6-month pre-treatment period;
- Plasma iPTH levels > 300 pg/mL, AND
- Plasma Ca levels > 9.4 mg/dL (with normal serum albumin level), AND
- Plasma P levels <6.5 mg/dL in patients younger than 6 years, or <6.0mg/dL in older patients, OR
- Ca x P product > 60;
- Records' availability for the following parameters 6 months prior to study entry: demographic information, physical examination, height and dry weight, auxological/anthropometric indices, blood pressure values, Kt/V urea, plasma iPTH, calcium, phosphorus, and alkaline phosphatise levels, blood pH and bicarbonate, serum creatinine/urea, C reactive protein (CRP) levels, liver function tests, blood count, blood 25(OH) vitamin D3 level.
Exclusion Criteria:
- The following laboratory values: Hb<9.0 g/dL, WBC<2000/mm3 (2x109/L), platelets <150,000/mm3 (150x109/L) only in subjects who are otherwise eligible for PK/PD assessments; abnormal liver function, defined by a total bilirubin ≥2 times the upper limit of normal values, ASAT, ALAT, γ-GT levels ≥2 times the ULN values.
- Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study.
- History of malignancy (active malignancy, or off therapy since less than 1 year)
- History of diseases causing hypercalcemia
- Chronic inflammatory diseases (C-Reactive Protein-CRP >2 times the upper limit of normal values) requiring a concomitant corticosteroid or immunosuppressive therapy
- History of infectious diseases (including opportunistic infections) within 4 weeks prior to study entry
- Evidence as assessed by the Investigator of active or latent bacterial, viral or fungal infections at the time of potential enrollment, including subjects with evidence of HIV infection.
- Hepatitis-B surface antigen-positive subjects only in subjects who are otherwise eligible for PK/PD assessments
- Hepatitis C antibody-positive subjects who are also PCR-positive or RIBA positive only in subjects who are otherwise eligible for PK/PD assessments
- Use of recombinant human growth hormone therapy
- Use of drugs that interact with cinacalcet disposition
- Previous use of cinacalcet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: cinacalcet tab or extemporaneous solution po added to SoC
Subjects who meet all inclusion/exclusion criteria at baseline will be given cinacalcet 30mg film-coated tablet, for oral use added to phosphate binders and vitamin D analogue. For subjects receiving a cinacalcet dose <30mg, commercially available cinacalcet 30mg tab will be ground and diluted with a 5% dextrose solution. Then, an aliquot of this solution corresponding to the individually prescribed dose will be administered as indicated. Initial dosing of cinacalcet will be 0.5-0.75mg/kg or 30 mg po once daily (OD) each evening with food. During the cinacalcet dose-titration 6-month period for efficacy assessment, the dose will be increased on monthly basis by 0.5 mg/kg or by 30mg OD to achieve the target iPTH value <180 pg/mL, as tolerated by the subject, up to maximum of 180mg OD in absence of signs of hypocalcemia, according to the current summary of product characteristics. |
The 6-month pre-treatment period will be followed by a run-in period with a baseline evaluation prior to the drug administration, followed by a 6-month cinacalcet dose titration period, during which the dose will be increased on monthly basis by 0.5 mg/kg or by 30 mg OD up to the achievement of target iPTH value <180 pg/mL as tolerated by the patient
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite EP, e.g. the proportion of patients who will have a reduction from baseline of >= 25% in mean iPTH levels with concomitant values for plasma P <6 mg/dL and Ca between 8.4 and 10.5 mg/dL or the Ca x P product <60
Time Frame: 6 months
|
This composite EP will address the needed information on the appropriate dose of cinacalcet to be adopted in paediatric patients, and especially in younger children, as well as on the impact of treatment with calcimimetics on serum Ca and P levels, and on SHPT control over the long term
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The long term control of iPTH level < 300 pg/mL
Time Frame: 18 months
|
18 months
|
The long term control of PTH, Ca, P, and the Ca x P product values
Time Frame: 18 months
|
18 months
|
The PK/ PD ( iPTH and testosterone) profile at individual patient level
Time Frame: 12 months
|
12 months
|
The long term auxological indices and patient growth velocity during cinacalcet treatment
Time Frame: 18 months
|
18 months
|
The proportion of patients with treatment-emergent adverse events (AEs), serious AEs (SAEs), and laboratory abnormalities over long term
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enrico E. Verrina, MD, U.O. Nefrologia e Dialisi; Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini
Publications and helpful links
General Publications
- Klaus G, Watson A, Edefonti A, Fischbach M, Ronnholm K, Schaefer F, Simkova E, Stefanidis CJ, Strazdins V, Vande Walle J, Schroder C, Zurowska A, Ekim M; European Pediatric Dialysis Working Group (EPDWG). Prevention and treatment of renal osteodystrophy in children on chronic renal failure: European guidelines. Pediatr Nephrol. 2006 Feb;21(2):151-9. doi: 10.1007/s00467-005-2082-7. Epub 2005 Oct 25.
- Silverstein DM, Kher KK, Moudgil A, Khurana M, Wilcox J, Moylan K. Cinacalcet is efficacious in pediatric dialysis patients. Pediatr Nephrol. 2008 Oct;23(10):1817-22. doi: 10.1007/s00467-007-0742-5. Epub 2008 Feb 21.
- Muscheites J, Wigger M, Drueckler E, Fischer DC, Kundt G, Haffner D. Cinacalcet for secondary hyperparathyroidism in children with end-stage renal disease. Pediatr Nephrol. 2008 Oct;23(10):1823-9. doi: 10.1007/s00467-008-0810-5. Epub 2008 May 27.
- Platt C, Inward C, McGraw M, Dudley J, Tizard J, Burren C, Saleem MA. Middle-term use of Cinacalcet in paediatric dialysis patients. Pediatr Nephrol. 2010 Jan;25(1):143-8. doi: 10.1007/s00467-009-1294-7. Epub 2009 Oct 17.
- Harris RZ, Padhi D, Marbury TC, Noveck RJ, Salfi M, Sullivan JT. Pharmacokinetics, pharmacodynamics, and safety of cinacalcet hydrochloride in hemodialysis patients at doses up to 200 mg once daily. Am J Kidney Dis. 2004 Dec;44(6):1070-6. doi: 10.1053/j.ajkd.2004.08.029.
- Padhi D, Harris RZ, Salfi M, Noveck RJ, Sullivan JT. Pharmacokinetics and pharmacodynamics of cinacalcet in hepatic impairment : phase I, open-label, parallel-group, single-dose, single-centre study. Clin Drug Investig. 2008;28(10):635-43. doi: 10.2165/00044011-200828100-00004.
- Cangemi G, Barco S, Verrina EE, Scurati S, Melioli G, Della Casa Alberighi O. Micromethod for quantification of cinacalcet in human plasma by liquid chromatography-tandem mass spectrometry using a stable isotope-labeled internal standard. Ther Drug Monit. 2013 Feb;35(1):112-7. doi: 10.1097/FTD.0b013e318278dc69.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Parathyroid Diseases
- Neoplastic Processes
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Neoplasm Metastasis
- Hyperparathyroidism, Secondary
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Calcium-Regulating Hormones and Agents
- Calcimimetic Agents
- Cinacalcet
Other Study ID Numbers
- IGG_ev_003
- 2009-016797-32 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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