Chronic Kidney Disease
Conditions
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 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
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.
Interventions
DRUGsevelamer carbonate, sevelamer hydrochloride
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
DRUGsevelamer hydrochloride, sevelamer carbonate
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety-evaluated on the basis of adverse events (reported and/or observed) | 16 weeks |
| changes in laboratory parameters, vital signs | 16 weeks |
| note: clinically significant changes in physical examination were recorded and evaluated as adverse events | 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 | 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. | 16 weeks |
Countries
United States
Outcome results
None listed