Phase 2 N=101 Randomized Double-blind Treatment

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

Hyperphosphatemia · Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01574326 ↗

Enrolled (actual)

101

Serious AEs

18.0%

Results posted

Jul 2016

Primary outcome: Primary: Change From Baseline (Week 0) to Week 2 in Serum Phosphorus — 7.2; 7.2; 7.24; 6.34 mg/dL — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Sevelamer carbonate (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: Genzyme, a Sanofi Company
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (Week 0) to Week 2 in Serum Phosphorus	7.2; 7.2; 7.24; 6.34; 0.04; -0.87	0.001 sig
PRIMARY Treatment - Emergent Adverse Events (AEs)	20; 19; 3; 2; 1; 4	—
SECONDARY Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus	7.05; 7.28; 5.92; 6.04; -1.13; -1.23	—

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

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01574326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.