Status:
COMPLETED
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00440648
Start Date
March 1 2005
End Date
July 1 2006
Last Update
March 19 2014
Active Locations (15)
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1
Mobile, Alabama, United States, 36608
2
Riverside, California, United States, 92501
3
Greenwood Village, Colorado, United States, 80111
4
Berwyn, Illinois, United States, 60402