Phase 2
Completed N=101
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Hyperphosphatemia · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01574326 ↗
Enrolled (actual)
101
Serious AEs
18.0%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline (Week 0) to Week 2 in Serum Phosphorus — 7.2; 7.2; 7.24; 6.34 mg/dL — p=0.001
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
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 | — |
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.
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. Informational only — not medical advice.