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Completed

NCT Number: NCT01574326

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

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

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Key information

Conditions

Hyperphosphatemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 8101, Bordeaux, France

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About this study

The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
  • The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion criteria

  • The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
  • The participant had a non-renal case of hyperphosphatemia.

Treatment and study plan

Placebo

Drug

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

Sevelamer carbonate

Drug

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

Other names: Renvela®

Primary outcomes

  1. Change From Baseline (Week 0) to Week 2 in Serum Phosphorus

    Time frame: Baseline, Week 2

    Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.

  2. Treatment - Emergent Adverse Events (AEs)

    Time frame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

    A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.

Secondary outcomes

  1. Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus

    Time frame: Baseline, Week 28/Early Termination

    Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2012
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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