Head to Head Study Against Sevelamer Hydrochloride

Condition(s) targeted: Chronic Kidney Disease, Stage 5

Intervention: Lanthanum Carbonate (Drug); Sevelamer hydrochloride (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Shire Pharmaceutical Development

Official(s) and/or principal investigator(s):
Stuart Sprague, D.O., Principal Investigator, Affiliation: Evanston Northwestern Hospital

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

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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in serum phosphorus levels at the end of each treatment period.

Secondary outcome: Serum phosphorus, calcium and PTH at each visit.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

KfH Dialysezentrum/Berlin, Berlin 12045, Germany

Dialysezentrum Barmbeck, Hamburg 22297, Germany

KfH Nierenzentrum/Dulmen, Dulmen 48249, Germany

KfH Nierenzentrum, Berlin 10559, Germany

Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie, Gottingen 37075, Germany

KfH Nierenzentrum/Bad/Konig, Bad Konig 64732, Germany

KfH-Nierenzentrum/Jena, Jena 07751, Germany

KfH-Dialysezentrum/Rosenheim, Rosenheim 83022, Germany

San Juan 00918, Puerto Rico

Churchill Hospital Oxford Kidney Unit, Oxford OX3 7LJ, United Kingdom

Southwest Kidney Institute, PLC, Tempe, Arizona 85284, United States

AKDHC Medical Research Services, LLC, Phoenix, Arizona 85012, United States

Southwest Kidney Institute, PLC, Tempe, Arizona 85284, United States

University of Arizona Health Service Center, Tuscon, Arizona 85724, United States

DSI Renal Inc., Mesa, Arizona 85202, United States

Tempe, Arizona 85284, United States

Clinical Research Connections, Jonesboro, Arkansas 72401, United States

South Valley Dialysis Center, Encino, California 91316, United States

North Valley Nephrology, Yuba City, California 95991, United States

VA Greater Los Angeles Health Care System, West LA, Los Angeles, California 90073, United States

Apex Research of Riverside, Riverside, California 92505, United States

Western Nephrology & Metabolic Bone Disease, PC, Thornton, Colorado 80260, United States

Pines Clinical Research, Pembroke Pines, Florida 33028, United States

Discovery Medical Research Group, Ocala, Florida 34471, United States

Shands University of Florida Outpatient Dialysis, Gainesville, Florida 32608, United States

Clinical Research Center of Indian River Medical Center, Vero Beach, Florida, United States

Renal Physicians of Georgia, Macon, Georgia 31217, United States

Kidney Care Associates, LLC, Augusta, Georgia 30901, United States

Research by Design, LLC, Evergreen Park, Illinois 60805, United States

Evanston Northwestern Hospital, Evanston, Illinois 60201, United States

Nephrology Inc., Mishawaka, Indiana 46545, United States

Renal Associates of Baton Rouge, Baton Rouge, Louisiana 70809, United States

Creighton University Medical Center, Omaha, Nebraska 68131, United States

Hypertension and Nephrology, Associates, Eatontown, New Jersey 07724, United States

Winthrop Dialysis Center, Mineola, New York 11501, United States

SUNY at Stony Brook NY, Stony Brook, New York 11794, United States

Wake Nephrology Associates, Raleigh, North Carolina 27609, United States

Southeastern Nephrology Associates, Wilmington, North Carolina 28401, United States

Northwest Renal Clinic, Portland, Oregon 97210, United States

Carolina Nephrology, PA, Greenville, South Carolina 29605, United States

VA Tennessee Valley Healthcare System, Nashville, Tennessee 37212, United States

University of Texas Health Science Center at San Antonio Medicine/Nephrology, San Antonio, Texas 78229, United States

Alexandria Kidney, Alexandria, Virginia 22304, United States

Clinical Research & Consulting Center, LLC, Fairfax, Virginia 22030, United States

Starting date: February 2007
Ending date: July 2008
Last updated: June 16, 2008