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An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

NCT01574326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2016-07-25

Study results available
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Summary

Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

* Evaluate the safety and tolerability of sevelamer carbonate
* Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

Conditions

Interventions

DRUG

Placebo

Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

DRUG

Sevelamer carbonate

0.8 g sachets of powder for oral suspension or 800 mg tablets

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • France
  • Germany
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574326 on ClinicalTrials.gov