Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

NCT ID: NCT00440648

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-07-31

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)

Group Type: OTHER

sevelamer carbonate, sevelamer hydrochloride

Intervention Type: DRUG

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

2

sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)

Group Type: OTHER

sevelamer hydrochloride, sevelamer carbonate

Intervention Type: DRUG

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Interventions

sevelamer carbonate, sevelamer hydrochloride

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Intervention Type: DRUG

sevelamer hydrochloride, sevelamer carbonate

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Mobile, Alabama, United States

Riverside, California, United States

Greenwood Village, Colorado, United States

Berwyn, Illinois, United States

Crestwood, Illinois, United States

Indianapolis, Indiana, United States

Valparaiso, Indiana, United States

Columbus, Missouri, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

Winston-Salem, North Carolina, United States

Easton, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Nashville, Tennessee, United States

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

GD3-163-201

Identifier Type: -

Identifier Source: org_study_id