Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis (LEAP)

April 15, 2015 updated by: Genzyme, a Sanofi Company

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis

The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Alexander City, Alabama, United States
      • Birmingham, Alabama, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Los Angeles, California, United States
      • Paramount, California, United States
      • Pembroke Pines, California, United States
      • Porterville, California, United States
      • Riverside, California, United States
      • San Dimas, California, United States
      • Whittier, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Hudson, Florida, United States
      • Ocala, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Gurnee, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Bethesda, Maryland, United States
    • Michigan
      • Pontiac, Michigan, United States
      • Southfield, Michigan, United States
    • Mississippi
      • Brookhaven, Mississippi, United States
      • Gulfport, Mississippi, United States
    • Missouri
      • St Louis, Missouri, United States
    • Nebraska
      • Kearney, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Bellmore, New York, United States
      • Bronx, New York, United States
      • Brooklyn, New York, United States
      • Buffalo, New York, United States
      • New York, New York, United States
      • Port Washington, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Lewistown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Sumter, South Carolina, United States
    • Tennessee
      • Columbia, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Alexandria, Virginia, United States
    • Wisconsin
      • Glendale, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
  • Men or women 18 years or older

Exclusion Criteria:

  • Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Drug: Placebo
Experimental: Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Experimental: Genz-644470 4.8 g/day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Experimental: Genz-644470 7.2 g/day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Active Comparator: Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Names:
  • Renvela®
Active Comparator: Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Names:
  • Renvela®
Active Comparator: Sevelamer Carbonate 7.2 g/day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Names:
  • Renvela®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Time Frame: Baseline, Day 22
Baseline, Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Time Frame: Baseline, Day 22
Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Time Frame: Baseline, Day 22
Baseline, Day 22
Change From Baseline in Total Cholesterol at Day 22
Time Frame: Baseline, Day 22
Baseline, Day 22
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Time Frame: Baseline, Day 22
Baseline, Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APB00108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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