An Open Label, Dose Titration Study Of Sevelamer Carbonate Dosed Three Times A Day In Hyperphosphatemic Chronic Kidney Disease (CKD) Patients Not On Dialysis

Recruiting

• Conditions: Renal and Urogenital - Kidney disease; Hyperphosphatemia in CKD Patients not on Dialysis

• Registration Number: ACTRN12606000380594
• Lead Sponsor: Genzyme Corporation, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

CKD patients not on dialysis; documented hyperphosphatemia without the use of a phosphate binder or after washout from current phosphate binder; signed informed consent.

Exclusion Criteria

Known hypersensitivity to the investigational product or any constituents of the study drug; active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders; in the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition; pregnant or breast-feeding; evidence of active malignancy except for basal cell carcinoma of the skin; unable to comply with the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline (Day 0) to Day 56/early termination (ET) in serum phosphorus.[At baseline (day 0) and day 56]

Secondary Outcome Measures

Name	Time	Method
Serum calcium-phosphorus product[Baseline and study day 56.];Serum lipid profile[Baseline and study day 56.];Percent responders[Baseline and study day 56.]