Head to Head Study Against Sevelamer Hydrochloride
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
2 other identifiers
interventional
182
4 countries
44
Brief Summary
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2007
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2008
CompletedResults Posted
Study results publicly available
August 13, 2009
CompletedJune 11, 2021
June 1, 2021
1.6 years
February 27, 2007
June 29, 2009
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
4 weeks
Secondary Outcomes (3)
Change From Baseline in Serum Calcium Levels at 4 Weeks
4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
4 weeks
Study Arms (2)
1
EXPERIMENTALFosrenol (Lanthanum carbonate)
2
ACTIVE COMPARATORSevelamer hydrochloride
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults with end stage renal disease who are receiving dialysis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (44)
DSI Renal Inc.
Mesa, Arizona, 85202, United States
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012, United States
Southwest Kidney Institute, PLC
Tempe, Arizona, 85284, United States
Unknown Facility
Tempe, Arizona, 85284, United States
University of Arizona Health Service Center
Tucson, Arizona, 85724, United States
Clinical Research Connections
Jonesboro, Arkansas, 72401, United States
South Valley Dialysis Center
Encino, California, 91316, 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
North Valley Nephrology
Yuba City, California, 95991, United States
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, 80260, United States
Shands University of Florida Outpatient Dialysis
Gainesville, Florida, 32608, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Pines Clinical Research
Pembroke Pines, Florida, 33028, United States
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, United States
Kidney Care Associates, LLC
Augusta, Georgia, 30901, United States
Renal Physicians of Georgia
Macon, Georgia, 31217, United States
Evanston Northwestern Hospital
Evanston, Illinois, 60201, United States
Research by Design, LLC
Evergreen Park, Illinois, 60805, 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
Rosa Verde Tower
San Antonio, Texas, 78205, 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
KfH Nierenzentrum/Bad/Konig
Bad König, 64732, Germany
KfH Nierenzentrum
Berlin, 10559, Germany
KfH Dialysezentrum/Berlin
Berlin, 12045, Germany
KfH Nierenzentrum/Dulmen
Dülmen, 48249, Germany
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
Göttingen, 37075, Germany
Dialysezentrum Barmbeck
Hamburg, 22297, Germany
KfH-Nierenzentrum/Jena
Jena, 07751, Germany
KfH-Dialysezentrum/Rosenheim
Rosenheim, 83022, Germany
Jose Cangiano, MD
San Juan, 00918, Puerto Rico
Churchill Hospital Oxford Kidney Unit
Oxford, OX3 7LJ, United Kingdom
Related Publications (2)
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.
PMID: 19825330BACKGROUNDNatale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
January 5, 2007
Primary Completion
July 31, 2008
Study Completion
July 31, 2008
Last Updated
June 11, 2021
Results First Posted
August 13, 2009
Record last verified: 2021-06