Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440648
• Other study ID #: GD3-163-201
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2007
• Last updated: March 17, 2014
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• sevelamer carbonate, sevelamer hydrochloride
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
• sevelamer hydrochloride, sevelamer carbonate
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety-evaluated on the basis of adverse events (reported and/or observed)		16 weeks	Yes
Primary	changes in laboratory parameters, vital signs		16 weeks	Yes
Primary	note: clinically significant changes in physical examination were recorded and evaluated as adverse events		16 weeks	Yes
Primary	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	No
Primary	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	No