Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: sevelamer carbonate, sevelamer hydrochloride
* Drug: sevelamer hydrochloride, sevelamer carbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16) | Drug: sevelamer carbonate, sevelamer hydrochloride<br>* Starting dose individualized for each patient and fixed daily dose throughout both treatment periods<br>|
| Other: 2<br>sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16) | Drug: sevelamer hydrochloride, sevelamer carbonate<br>* Starting dose individualized for each patient and fixed daily dose throughout both treatment periods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |