Pediatric Chronic Kidney Disease Safety and Efficacy

Chronic Kidney Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277510
• Other study ID #: 20070208
• Status: Terminated
• Phase: Phase 3
• Start date: June 28, 2011

Study information

• Verified date: June 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Description:

Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age 6 to less than 18 years at screening

• Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for = 2 months before randomization

• Dry weight = 12.5 kg at screening

• iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)

• Serum calcium (corrected) obtained from the central laboratory must be = 8.8 mg/dL (2.2 mmol/L)

• Serum phosphorus obtained from the central laboratory = 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or = 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old

• Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization

• Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization

• Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization

• Subjects must be on a dialysate calcium concentration of = 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization

Exclusion Criteria:

• Underwent parathyroidectomy in the last 6 months

• Anticipated parathyroidectomy within 6 months after randomization

• Received therapy with cinacalcet (sensipar/mimpara) within the last month

• A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months

• Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Disease
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• cinacalcet capsule
Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
• placebo
Placebo tablets and capsules for sprinkling identical to active treatment.
• Standard of Care
All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.

Locations

Country	Name	City	State
Australia	Research Site	Herston	Queensland
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	Westmead	New South Wales
Belgium	Research Site	Bruxelles
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Germany	Research Site	Heidelberg
Germany	Research Site	Marburg
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Pecs
Hungary	Research Site	Szeged
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Mexico	Distrito Federal
Poland	Research Site	Gdansk
Poland	Research Site	Gorzow Wielkopolski
Poland	Research Site	Lodz
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Spain	Research Site	Baracaldo	PaÃ-s Vasco
Spain	Research Site	Baracaldo	País Vasco
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Valencia	Comunidad Valenciana
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Gainesville	Florida
United States	Research Site	Greenville	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Livingston	New Jersey
United States	Research Site	Los Angeles	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Hungary,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain, 

References & Publications (2)

Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30. — View Citation

Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 May 4. doi: 10.1007/s00467-020-04516-4. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving = 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to the Efficacy Assessment Phase, Weeks 25-30
Secondary	Percentage of Participants Achieving Mean iPTH = 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
Secondary	Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period	Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."	From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Secondary	Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Secondary	Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Secondary	Growth Velocity From Baseline to End of Double-blind Phase	Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.	From Baseline to end of Efficacy Assessment at Week 30
Secondary	Growth Velocity From End of Double-blind Phase to End of Open-label Phase	Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.	End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
Secondary	Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

External Links

•   AmgenTrials clinical trials website