Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Sevelamer

Criteria

Inclusion Criteria:

• patient had received hemodialysis three times per week for 3 months or longer;

• patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.

Exclusion Criteria:

• if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;

• active ethanol or drug abuse (excluding tobacco);

• need for antidysrhythmic or antiseizure medications used to control these conditions;

• poorly controlled diabetes mellitus or hypertension;

• active vasculitis;

• active malignancy other than basal-cell carcinoma;

• HIV infection; or

• any clinically significant unstable medical condition as judge by the Investigator.