Head to Head Study Against Sevelamer Hydrochloride

June 4, 2021 updated by: Shire

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Konig, Germany, 64732
        • KfH Nierenzentrum/Bad/Konig
      • Berlin, Germany, 10559
        • KfH Nierenzentrum
      • Berlin, Germany, 12045
        • KfH Dialysezentrum/Berlin
      • Dulmen, Germany, 48249
        • KfH Nierenzentrum/Dulmen
      • Gottingen, Germany, 37075
        • Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
      • Hamburg, Germany, 22297
        • Dialysezentrum Barmbeck
      • Jena, Germany, 07751
        • KfH-Nierenzentrum/Jena
      • Rosenheim, Germany, 83022
        • KfH-Dialysezentrum/Rosenheim
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Jose Cangiano, MD
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital Oxford Kidney Unit
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • DSI Renal Inc.
      • Phoenix, Arizona, United States, 85012
        • AKDHC Medical Research Services, LLC
      • Tempe, Arizona, United States, 85284
      • Tempe, Arizona, United States, 85284
        • Southwest Kidney Institute, PLC
      • Tucson, Arizona, United States, 85724
        • University of Arizona Health Service Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Clinical Research Connections
    • California
      • Encino, California, United States, 91316
        • South Valley Dialysis Center
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Health Care System, West LA
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Yuba City, California, United States, 95991
        • North Valley Nephrology
    • Colorado
      • Thornton, Colorado, United States, 80260
        • Western Nephrology & Metabolic Bone Disease, PC
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands University of Florida Outpatient Dialysis
      • Ocala, Florida, United States, 34471
        • Discovery Medical Research Group
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research
      • Vero Beach, Florida, United States
        • Clinical Research Center of Indian River Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Kidney Care Associates, LLC
      • Macon, Georgia, United States, 31217
        • Renal Physicians of Georgia
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Hospital
      • Evergreen Park, Illinois, United States, 60805
        • Research by Design, LLC
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Nephrology Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Renal Associates of Baton Rouge
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Hypertension and Nephrology, Associates
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop Dialysis Center
      • Stony Brook, New York, United States, 11794
        • SUNY at Stony Brook NY
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Wake Nephrology Associates
      • Wilmington, North Carolina, United States, 28401
        • Southeastern Nephrology Associates
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Renal Clinic
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Carolina Nephrology, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • VA Tennessee Valley Healthcare System
    • Texas
      • San Antonio, Texas, United States, 78205
        • Rosa Verde Tower
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio Medicine/Nephrology
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Alexandria Kidney
      • Fairfax, Virginia, United States, 22030
        • Clinical Research & Consulting Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Fosrenol (Lanthanum carbonate)
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.
Other Names:
  • FOSRENOL
ACTIVE_COMPARATOR: 2
Sevelamer hydrochloride
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Serum Calcium Levels at 4 Weeks
Time Frame: 4 weeks
4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2007

Primary Completion (ACTUAL)

July 31, 2008

Study Completion (ACTUAL)

July 31, 2008

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (ESTIMATE)

March 1, 2007

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD405-319
  • 2006-004959-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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