Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
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:
1. sevelamer dosed once a day with the largest meal followed by standard three times per
day dosing with meals
2. sevelamer dosed three times per day with meals followed by once a day dosing with the
largest meal. Patients will maintain a fixed daily dose throughout both treatment
periods based on the most recently prescribed sevelamer dose prior to screening.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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