GD3-163-201: Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00440648

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: Sevelamer hydrochloride Drug: Sevelamer carbonate	Phase 2

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind, Active Control, Crossover

Assignment, Safety/Efficacy Study

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

Further Study Details:

Primary Outcome Measures:

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.

Expected Total Enrollment: 80

Study start: 2005-03

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

Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: 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.

Location and Contact Information

Alabama
Mobile, Alabama, 36608, United States

California
Riverside, California, 92501, United States

Colorado
Greenwood Village, Colorado, 80111, United States

Illinois
Crestwood, Illinois, 60445, United States
Berwyn, Illinois, 60402, United States

Indiana
Valparaiso, Indiana, 46383, United States
Indianapolis, Indiana, 46202, United States

Missouri
St. Louis, Missouri, 63110, United States
Columbus, Missouri, 39705, United States
St. Louis, Missouri, 63103, United States

North Carolina
Winston-Salem, North Carolina, 27157, United States

Pennsylvania
Easton, Pennsylvania, 19045, United States
Wynnewood, Pennsylvania, 19096, United States

Tennessee
Nashville, Tennessee, 37205, United States

Virginia
Norfolk, Virginia, 23507, United States

More Information

Study ID Numbers: GD3-163-201
ClinicalTrials.gov Identifier: NCT00440648
Health Authority: United States: Food and Drug Administration