Pediatric Chronic Kidney Disease Safety and Efficacy

Phase 3TerminatedNCT01277510

Amgen43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Kidney Disease Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Disease Secondary Hyperparathyroidism

Interventions

cinacalcet capsuleDRUG

Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

placeboDRUG

Placebo tablets and capsules for sprinkling identical to active treatment.

Standard of CareDRUG

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

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.

Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30

Secondary Outcomes

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.

Time frame: From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30

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."

Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Gainesville, Florida, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Kansas City, Missouri, United States

Research Site

St Louis, Missouri, United States

Research Site

St Louis, Missouri, United States

Research Site

Livingston, New Jersey, United States

...and 41 more locations