Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: sevelamer carbonate, sevelamer hydrochloride; Drug: sevelamer hydrochloride, sevelamer carbonate

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
  • California
    • Riverside, California, United States, 92501
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
  • Illinois
    • Berwyn, Illinois, United States, 60402
    • Crestwood, Illinois, United States, 60445
  • Indiana
    • Indianapolis, Indiana, United States, 46202
    • Valparaiso, Indiana, United States, 46383
  • Missouri
    • Columbus, Missouri, United States, 39705
    • St. Louis, Missouri, United States, 63110
    • St. Louis, Missouri, United States, 63103
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
  • Pennsylvania
    • Easton, Pennsylvania, United States, 19045
    • Wynnewood, Pennsylvania, United States, 19096
  • Tennessee
    • Nashville, Tennessee, United States, 37205
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)	Drug: sevelamer carbonate, sevelamer hydrochloride; Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Other: 2; sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)	Drug: sevelamer hydrochloride, sevelamer carbonate; Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety-evaluated on the basis of adverse events (reported and/or observed)	16 weeks
changes in laboratory parameters, vital signs	16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events	16 weeks
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
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

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: February 24, 2007
• First Submitted That Met QC Criteria: February 24, 2007
• First Posted (Estimate): February 27, 2007

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: GD3-163-201