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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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