Clinical trial NCT00440648: Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Official title: A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety-evaluated on the basis of adverse events (reported and/or observed)
timeFrame: 16 weeks
measure: changes in laboratory parameters, vital signs
timeFrame: 16 weeks
measure: note: clinically significant changes in physical examination were recorded and evaluated as adverse events
timeFrame: 16 weeks
measure: 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
timeFrame: 16 weeks
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Riverside
country: United States
state: California
city: Greenwood Village
country: United States
state: Colorado
city: Berwyn
country: United States
state: Illinois
city: Crestwood
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Columbus
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Easton
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: