Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

March 17, 2014 updated by: Genzyme, a Sanofi Company

A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Clinical Research Center
      • Gadsden, Alabama, United States, 35901
        • Gadsden Dialysis
    • California
      • Mission Hills, California, United States, 91345
        • Holy Cross Renal Care
      • Tarzana, California, United States, 91356
        • Nephrology Educational Services and Research
    • Florida
      • Crystal River, Florida, United States, 34429
        • Crystal Rivers Dialysis Center
      • Hudson, Florida, United States, 34667
        • Outcomes Research International, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Central Dialysis Center
      • Decatur, Georgia, United States, 30030
        • Atlanta Nephrology Referral Center
      • Marietta, Georgia, United States, 30066
        • FMC Marietta
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Horizon Healthcare Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation, Nephrology Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Southwest Mississippi Nephrology, PLLC
      • Columbus, Mississippi, United States, 39705
        • Nephrology Associates, P.C.
      • Tupelo, Mississippi, United States, 38801
        • Nephrology & Hypertension Associates, LTD
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Hypertension and Nephrology Associates
    • New York
      • Bronx, New York, United States, 10461
        • Davita
      • Mineola, New York, United States, 11501
        • Winthrop University Dialysis Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Kidney and Hypertension Center
      • Cleveland, Ohio, United States, 44109
        • Renal Care Group
    • Pennsylvania
      • Lewistown, Pennsylvania, United States, 17044
        • Lewiston Dialysis Center
    • Tennessee
      • Dyersburg, Tennessee, United States, 38024
        • Medical Nephrology Associates
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates, P.C.
    • Texas
      • Houston, Texas, United States, 77054
        • Renal Research Inc. at the Kidney Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Gambro Healthcare - Charlottesville
      • Norfolk, Virginia, United States, 23507
        • Clinical Research of Tidewater
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University, Division of Nephrology

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On three times per week hemodialysis for three months or longer
  • Currently on a phosphate binder(s)
  • Considered compliant with phosphate binders and hemodialysis therapy
  • Willing to avoid any intentional changes in diet such as fasting or dieting
  • Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
  • Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
  • Have not participated in any other investigational drug studies within 30 days prior to enrollment
  • Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
  • Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
  • Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
  • Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
  • If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
  • Life expectancy of 12 months or greater
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
  • Active ethanol or drug abuse, excluding tobacco use
  • In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
  • Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
  • Known hypersensitivity to sevelamer or any constituents of the study drug
  • Pregnant or breast-feeding
  • Evidence of active malignancy except for basal cell carcinoma of the skin
  • Unable to comply with the requirements of the study
  • Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
sevelamer carbonate powder
Drug: Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
Active Comparator: 2
Sevelamer hydrochloride
Drug: Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Time Frame: Up to 24 weeks
Up to 24 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

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

January 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GD3-199-301

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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