Clinical trial NCT00441545: Head to Head Study Against Sevelamer Hydrochloride
Official title: A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease, Stage 5
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Detailed description: To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Eligibility criteria: Inclusion Criteria:

* Adults with end stage renal disease who are receiving dialysis

Exclusion Criteria:

* Subjects with significant gastrointestinal disorders
* Subjects who are pregnant or nursing
* Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
* Subjects who are HIV positive
* Subjects with clinical significant liver disease

Primary outcomes:
measure: Change From Baseline in Serum Phosphorus Levels at 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in Serum Calcium Levels at 4 Weeks
timeFrame: 4 weeks
measure: Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: DSI Renal Inc.
state: Arizona
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Tempe
country: United States
facility: Southwest Kidney Institute, PLC
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Service Center
state: Arizona
city: Jonesboro
country: United States
facility: Clinical Research Connections
state: Arkansas
city: Encino
country: United States
facility: South Valley Dialysis Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Health Care System, West LA
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Yuba City
country: United States
facility: North Valley Nephrology
state: California
city: Thornton
country: United States
facility: Western Nephrology & Metabolic Bone Disease, PC
state: Colorado
city: Gainesville
country: United States
facility: Shands University of Florida Outpatient Dialysis
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research
state: Florida
city: Vero Beach
country: United States
facility: Clinical Research Center of Indian River Medical Center
state: Florida
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Hospital
state: Illinois
city: Evergreen Park
country: United States
facility: Research by Design, LLC
state: Illinois
city: Mishawaka
country: United States
facility: Nephrology Inc.
state: Indiana
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Eatontown
country: United States
facility: Hypertension and Nephrology, Associates
state: New Jersey
city: Mineola
country: United States
facility: Winthrop Dialysis Center
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook NY
state: New York
city: Raleigh
country: United States
facility: Wake Nephrology Associates
state: North Carolina
city: Wilmington
country: United States
facility: Southeastern Nephrology Associates
state: North Carolina
city: Portland
country: United States
facility: Northwest Renal Clinic
state: Oregon
city: Greenville
country: United States
facility: Carolina Nephrology, PA
state: South Carolina
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare System
state: Tennessee
city: San Antonio
country: United States
facility: Rosa Verde Tower
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio Medicine/Nephrology
state: Texas
city: Alexandria
country: United States
facility: Alexandria Kidney
state: Virginia
city: Fairfax
country: United States
facility: Clinical Research & Consulting Center, LLC
state: Virginia
city: Bad Konig
country: Germany
facility: KfH Nierenzentrum/Bad/Konig
city: Berlin
country: Germany
facility: KfH Nierenzentrum
city: Berlin
country: Germany
facility: KfH Dialysezentrum/Berlin
city: Dulmen
country: Germany
facility: KfH Nierenzentrum/Dulmen
city: Gottingen
country: Germany
facility: Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
city: Hamburg
country: Germany
facility: Dialysezentrum Barmbeck
city: Jena
country: Germany
facility: KfH-Nierenzentrum/Jena
city: Rosenheim
country: Germany
facility: KfH-Dialysezentrum/Rosenheim
city: San Juan
country: Puerto Rico
facility: Jose Cangiano, MD
city: Oxford
country: United Kingdom
facility: Churchill Hospital Oxford Kidney Unit
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.