A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Safety-evaluated on the basis of adverse events (reported and/or observed)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1
sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
Intervention: sevelamer carbonate, sevelamer hydrochloride (Drug)
2
sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
Intervention: sevelamer hydrochloride, sevelamer carbonate (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported