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

Genzyme

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Treatments: Drug: Placebo; Drug: Sevelamer carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574326

DRI12793 (Other Identifier)

2011-002329-23 (EudraCT Number)

SVCARB07609

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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101 participants in 2 patient groups, including a placebo group

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate

Placebo Comparator group

Description:

Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).

Treatment:

Drug: Sevelamer carbonate

Drug: Placebo

FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Experimental group

Description:

Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.

Treatment:

Drug: Sevelamer carbonate

Drug: Placebo