Pediatric Chronic Kidney Disease Safety and Efficacy
Stopped: Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.
United States43 participantsStarted 2011-06-28
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
Timeframe: From Baseline to the Efficacy Assessment Phase, Weeks 25-30