A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis (ASPIRE)

Genzyme

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Treatments: Drug: Placebo for sevelamer carbonate; Drug: Sevelamer carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833768

SVCARB00606

Eudra CT: 2007-003885-16 (Registry Identifier)

Details and patient eligibility

About

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion criteria

• Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Sevelamer carbonate

Active Comparator group

Treatment:

Drug: Sevelamer carbonate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo for sevelamer carbonate