GTC68209: Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00324376

Purpose

A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title: A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Further Study Details:

Primary Outcomes: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.

Expected Total Enrollment: 24

Study Start: 2003-03

Eligibility

Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

life expectancy of at least 12 months,

patients have received hemodialysis three times per week for 3 months or longer,

patients maintained on sevelamer in a daily dose of ≤9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion Criteria:

active bowel obstruction,

dysphagia,

swallowing disorders,

severe gastrointestinal motility disorders,

bowel obstruction

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,

any clinically significant unstable medical condition as judged by the investigator.

Location Information

Illinois
Renal Care Group, Olympia Fields, Illinois, United States

Ohio
Kidney and Hypertension Center, Cincinnati, Ohio, United States

More Information

US FDA Approved Full Prescribing Information for Renagel®

Results synopsis for Clinical Trial Protocol GTC-68-209

Study ID Numbers: GTC-68-209
ClinicalTrials.gov Identifier: NCT00324376
Health Authority: United States: Food and Drug Administration