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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 101
- Locations
- 32
- Primary Endpoint
- Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Study Overview
Brief 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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
Intervention: Placebo (Drug)
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
Intervention: Sevelamer carbonate (Drug)
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
Intervention: Placebo (Drug)
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
Intervention: Sevelamer carbonate (Drug)
Outcomes
Primary Outcomes
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.
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
- Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus(Baseline, Week 28/Early Termination)