Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pediatric Chronic Kidney Disease Safety and Efficacy

This study has been terminated.
(Study was suspended in agreement between sponsor and FDA due to concerns about the study design after a fatality had occurred in the presence of hypocalcemia.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01277510
First received: January 13, 2011
Last updated: September 12, 2014
Last verified: September 2014

January 13, 2011
September 12, 2014
June 2011
February 2014   (final data collection date for primary outcome measure)
To demonstrate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone level (iPTH) by ≥ 30% [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01277510 on ClinicalTrials.gov Archive Site
  • To demonstrate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on corrected total serum calcium level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on serum phosphorus level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on the calcium x phosphorus product (Ca x P) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • Evaluate number of participants with adverse events, and frequency of episodes of hypocalcemia [ Time Frame: Throughout entire treatment period, up to 60 weeks ] [ Designated as safety issue: Yes ]
  • Measure change in height to assess overall growth velocity [ Time Frame: From baseline to end of Efficacy Assessment at Week 30, and from Week 30 to end of entire treatment at Week 60 ] [ Designated as safety issue: No ]
  • To measure the percent change in ionized calcium [ Time Frame: From baseline to the end of Efficacy Assessment Period up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on corrected total serum calcium level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on serum phosphorus level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • To demonstrate the impact of cinacalcet on the calcium x phosphorus product (Ca x P) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
  • Evaluate number of participants with adverse events, and frequency of episodes of hypocalcemia [ Time Frame: Throughout entire treatment period, up to 60 weeks ] [ Designated as safety issue: Yes ]
  • To demonstrate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pediatric Chronic Kidney Disease Safety and Efficacy
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

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, 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 parathyroid hormone in a larger number of pediatric subjects with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Hyperparathyroidism
  • Hyperparathyroidism, Secondary
  • Kidney Disease
  • Secondary Hyperparathyroidism
  • Drug: cinacalcet capsule
    For subjects who cannot swallow pills, supplied in 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.
    Other Name: Sensipar, Mimpara
  • Drug: placebo capsule

    For subjects who cannot swallow pills, supplied in 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg.

    Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.

  • Drug: cinacalcet tablet
    For subjects who can swallow pills, tablets supplied for titration in doses of 30, 60, 90, 120 and 180 mg in addition to 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.
    Other Name: Sensipar, Mimpara
  • Drug: placebo tablet

    For subjects who can swallow pills, tablets supplied for titration in doses of 30, 60, 90, 120 and 180 mg in addition to 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg.

    Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.

  • Placebo Comparator: placebo
    Placebo equivalants to both tablets and capsules are presented as visually identical to the active medication.
    Interventions:
    • Drug: placebo capsule
    • Drug: placebo tablet
  • Active Comparator: cinacalcet
    Tablets are presented as light green film-coated tablets graduated in size by strength with the smallest of the three being the lowest dose. Capsules are not commercially available but are opaque shells that can be opened so the contents can be sprinkled or mixed in syrup.
    Interventions:
    • Drug: cinacalcet capsule
    • Drug: cinacalcet tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain
 
NCT01277510
20070208
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP