Terminated/Withdrawn
Sponsor ID
20070208

Pediatric Chronic Kidney Disease Safety and Efficacy

Sponsor ID
20070208
Clinicaltrials.gov ID
NCT01277510
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
cinacalcet hcl
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
43
Additional Study Details

Protocol Summary

Primary Outcome Measures

To demonstrate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone level (iPTH) by ≥ 30%

Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

Secondary Outcome Measures

To demonstrate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L)

Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

To demonstrate the impact of cinacalcet on corrected total serum calcium level

Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

To demonstrate the impact of cinacalcet on serum phosphorus level

Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

To demonstrate the impact of cinacalcet on the calcium x phosphorus product (Ca x P)

Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

Evaluate number of participants with adverse events, and frequency of episodes of hypocalcemia

Timeframe: Throughout entire treatment period, up to 60 weeks

Measure change in height to assess overall growth velocity

Timeframe: From baseline to end of Efficacy Assessment at Week 30, and from Week 30 to end of entire treatment at Week 60

To measure the percent change in ionized calcium

Timeframe: From baseline to the end of Efficacy Assessment Period up to 30 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Gent, Belgium, 9000
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Edegem, Belgium, 2650
Status
Recruiting
Location
Research Site
Budapest, Hungary, 1083
Status
Recruiting
Location
Research Site
Szeged, Hungary, 6720
Status
Recruiting
Location
Research Site
Pecs, Hungary, 7623
Status
Recruiting
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