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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Hyperphosphatemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: Sevelamer carbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate<br>Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). | Drug: Placebo<br>* Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets<br>Drug: Sevelamer carbonate<br>* 0.8 g sachets of powder for oral suspension or 800 mg tablets<br>* Other names: Renvela®;|
| Experimental: FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate<br>Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP. | Drug: Placebo<br>* Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets<br>Drug: Sevelamer carbonate<br>* 0.8 g sachets of powder for oral suspension or 800 mg tablets<br>* Other names: Renvela®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Week 0) to Week 2 in Serum Phosphorus | 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. | Baseline, Week 2 | 
| Treatment - Emergent Adverse Events (AEs) | 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. | Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus | 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. | Baseline, Week 28/Early Termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Chronic Kidney Disease, Sevelamer Carbonate, Hyperphosphatemia