Clinical trial NCT00853242: Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Failure, Chronic
Keywords: Chronic Kidney Disease
Phosphate Binder
Phosphate
Hyperphosphatemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
timeFrame: Baseline, Day 22
Secondary outcomes:
measure: Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
timeFrame: Baseline, Day 22
measure: Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
timeFrame: Baseline, Day 22
measure: Change From Baseline in Total Cholesterol at Day 22
timeFrame: Baseline, Day 22
measure: Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
timeFrame: Baseline, Day 22
Other outcomes:
Locations:
city: Alexander City
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Paramount
country: United States
state: California
city: Pembroke Pines
country: United States
state: California
city: Porterville
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Whittier
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Hudson
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Gurnee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Pontiac
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Brookhaven
country: United States
state: Mississippi
city: Gulfport
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: Kearney
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Bellmore
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Port Washington
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Columbia
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Glendale
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: