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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
0.8 g sachets of powder for oral suspension or 800 mg tablets
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.
Time frame: 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.
Time frame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
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.
Time frame: Baseline, Week 28/Early Termination
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Investigational Site Number 8003
Birmingham, Alabama, United States
Investigational Site Number 8005
Birmingham, Alabama, United States
Investigational Site Number 8013
Los Angeles, California, United States
Investigational Site Number 8014
San Francisco, California, United States
Investigational Site Number 8025
Orlando, Florida, United States
Investigational Site Number 8007
Atlanta, Georgia, United States
Investigational Site Number 8019
Iowa City, Iowa, United States
Investigational Site Number 8012
Baltimore, Maryland, United States
Investigational Site Number 8008
Boston, Massachusetts, United States
Investigational Site Number 8020
Detroit, Michigan, United States
...and 22 more locations