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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Greenwood Village, Colorado, United States
Safety-evaluated on the basis of adverse events (reported and/or observed)
Time frame: 16 weeks
changes in laboratory parameters, vital signs
Time frame: 16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
Time frame: 16 weeks
Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
Time frame: 16 weeks
Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
Time frame: 16 weeks
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Unnamed facility
Berwyn, Illinois, United States
Unnamed facility
Crestwood, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Valparaiso, Indiana, United States
Unnamed facility
Columbus, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
...and 5 more locations