Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

Genzyme

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease on Hemodialysis; Chronic Kidney Disease

Treatments: Drug: Sevelamer carbonate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736150

SVCARB03808

Details and patient eligibility

About

The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
• Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
• Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a

Exclusion criteria

• Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
• Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 2 patient groups, including a placebo group

Sevelamer carbonate

Experimental group

Description:

Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.

Treatment:

Drug: Sevelamer carbonate

Placebo

Placebo Comparator group

Description:

Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.

Treatment:

Drug: Placebo