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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Genz-644470
Sevelamer carbonate
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Chronic Kidney Disease, Phosphate Binder, Phosphate, Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Genz-644470 2.4 Grams Per Day (g/day)

Genz-644470 4.8 g/day

Genz-644470 7.2 g/day

Sevelamer Carbonate 2.4 g/day

Sevelamer Carbonate 4.8 g/day

Sevelamer Carbonate 7.2 g/day

Arm Description

Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.

Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.

Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.

Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.

Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.

Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2009
Last Updated
April 15, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00853242
Brief Title
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Acronym
LEAP
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Chronic Kidney Disease, Phosphate Binder, Phosphate, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Arm Title
Genz-644470 2.4 Grams Per Day (g/day)
Arm Type
Experimental
Arm Description
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Arm Title
Genz-644470 4.8 g/day
Arm Type
Experimental
Arm Description
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Arm Title
Genz-644470 7.2 g/day
Arm Type
Experimental
Arm Description
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Arm Title
Sevelamer Carbonate 2.4 g/day
Arm Type
Active Comparator
Arm Description
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Arm Title
Sevelamer Carbonate 4.8 g/day
Arm Type
Active Comparator
Arm Description
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Arm Title
Sevelamer Carbonate 7.2 g/day
Arm Type
Active Comparator
Arm Description
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Genz-644470
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela®
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Time Frame
Baseline, Day 22
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Time Frame
Baseline, Day 22
Title
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Time Frame
Baseline, Day 22
Title
Change From Baseline in Total Cholesterol at Day 22
Time Frame
Baseline, Day 22
Title
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Time Frame
Baseline, Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Alexander City
State/Province
Alabama
Country
United States
City
Birmingham
State/Province
Alabama
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Paramount
State/Province
California
Country
United States
City
Pembroke Pines
State/Province
California
Country
United States
City
Porterville
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Dimas
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Hudson
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Pontiac
State/Province
Michigan
Country
United States
City
Southfield
State/Province
Michigan
Country
United States
City
Brookhaven
State/Province
Mississippi
Country
United States
City
Gulfport
State/Province
Mississippi
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
Kearney
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Bellmore
State/Province
New York
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
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New York
Country
United States
City
Port Washington
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Doylestown
State/Province
Pennsylvania
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Lewistown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Sumter
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
Tennessee
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Alexandria
State/Province
Virginia
Country
United States
City
Glendale
State/Province
Wisconsin
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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