Head to Head Study Against Sevelamer Hydrochloride

Chronic Kidney Disease, Stage 5 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441545
• Other study ID #: SPD405-319
• Secondary ID: 2006-004959-38
• Status: Completed
• Phase: Phase 3
• Start date: January 5, 2007
• Est. completion date: July 31, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 31, 2008
• Est. primary completion date: July 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease, Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Fosrenol (Lanthanum Carbonate)
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
• Sevelamer hydrochloride
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.

Locations

Country	Name	City	State
Germany	KfH Nierenzentrum/Bad/Konig	Bad Konig
Germany	KfH Dialysezentrum/Berlin	Berlin
Germany	KfH Nierenzentrum	Berlin
Germany	KfH Nierenzentrum/Dulmen	Dulmen
Germany	Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie	Gottingen
Germany	Dialysezentrum Barmbeck	Hamburg
Germany	KfH-Nierenzentrum/Jena	Jena
Germany	KfH-Dialysezentrum/Rosenheim	Rosenheim
Puerto Rico	Jose Cangiano, MD	San Juan
United Kingdom	Churchill Hospital Oxford Kidney Unit	Oxford
United States	Alexandria Kidney	Alexandria	Virginia
United States	Kidney Care Associates, LLC	Augusta	Georgia
United States	Renal Associates of Baton Rouge	Baton Rouge	Louisiana
United States	Hypertension and Nephrology, Associates	Eatontown	New Jersey
United States	South Valley Dialysis Center	Encino	California
United States	Evanston Northwestern Hospital	Evanston	Illinois
United States	Research by Design, LLC	Evergreen Park	Illinois
United States	Clinical Research & Consulting Center, LLC	Fairfax	Virginia
United States	Shands University of Florida Outpatient Dialysis	Gainesville	Florida
United States	Carolina Nephrology, PA	Greenville	South Carolina
United States	Clinical Research Connections	Jonesboro	Arkansas
United States	VA Greater Los Angeles Health Care System, West LA	Los Angeles	California
United States	Renal Physicians of Georgia	Macon	Georgia
United States	DSI Renal Inc.	Mesa	Arizona
United States	Winthrop Dialysis Center	Mineola	New York
United States	Nephrology Inc.	Mishawaka	Indiana
United States	VA Tennessee Valley Healthcare System	Nashville	Tennessee
United States	Discovery Medical Research Group	Ocala	Florida
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Pines Clinical Research	Pembroke Pines	Florida
United States	AKDHC Medical Research Services, LLC	Phoenix	Arizona
United States	Northwest Renal Clinic	Portland	Oregon
United States	Wake Nephrology Associates	Raleigh	North Carolina
United States	Apex Research of Riverside	Riverside	California
United States	Rosa Verde Tower	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio Medicine/Nephrology	San Antonio	Texas
United States	SUNY at Stony Brook NY	Stony Brook	New York
United States	Southwest Kidney Institute, PLC	Tempe	Arizona
United States	Western Nephrology & Metabolic Bone Disease, PC	Thornton	Colorado
United States	University of Arizona Health Service Center	Tucson	Arizona
United States	Clinical Research Center of Indian River Medical Center	Vero Beach	Florida
United States	Southeastern Nephrology Associates	Wilmington	North Carolina
United States	North Valley Nephrology	Yuba City	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Germany,  Puerto Rico,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum Phosphorus Levels at 4 Weeks		4 weeks
Secondary	Change From Baseline in Serum Calcium Levels at 4 Weeks		4 weeks
Secondary	Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks		Baseline and 4 weeks
Secondary	Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks	Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)	4 weeks

External Links

•   FDA recall information
•   FDA-approved label