Status:
COMPLETED
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- active bowel obstruction,
- dysphagia,
- swallowing disorders,
- 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,
- any clinically significant unstable medical condition as judged by the investigator.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00324376
Start Date
March 1 2003
End Date
May 1 2004
Last Update
March 5 2015
Active Locations (2)
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1
Renal Care Group
Olympia Fields, Illinois, United States
2
Kidney and Hypertension Center
Cincinnati, Ohio, United States