Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Sevelamer hydrochloride (Drug); Sevelamer carbonate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Andrew Blair, M.D., Study Director, Affiliation: Genzyme
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
Clinical Details
Official title: A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Safety-evaluated on the basis of adverse events (reported and/or observed)changes in laboratory parameters, vital signs note: clinically significant changes in physical examination were recorded and evaluated as adverse events 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 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mobile, Alabama 36608, United States
Riverside, California 92501, United States
Greenwood Village, Colorado 80111, United States
Crestwood, Illinois 60445, United States
Berwyn, Illinois 60402, United States
Valparaiso, Indiana 46383, United States
Indianapolis, Indiana 46202, United States
St. Louis, Missouri 63110, United States
Columbus, Missouri 39705, United States
St. Louis, Missouri 63103, United States
Winston-Salem, North Carolina 27157, United States
Easton, Pennsylvania 19045, United States
Wynnewood, Pennsylvania 19096, United States
Nashville, Tennessee 37205, United States
Norfolk, Virginia 23507, United States
Additional Information
Starting date: March 2005
Last updated: February 24, 2007
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