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

Last updated: March 17, 2014
Sponsor: Genzyme, a Sanofi Company
Overall Status: Completed

Phase

3

Condition

Kidney Failure (Pediatric)

Kidney Failure

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT00268957
GD3-199-301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 recentconsecutive 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 atscreening

  • Have not participated in any other investigational drug studies within 30 days priorto enrollment

  • Level of understanding and willingness to cooperate with all visits and procedures asdescribed by the study personnel

  • Willing and able to take sevelamer alone as a phosphate binder for the duration of thestudy

  • Willing and able to maintain screening doses of lipid medication for the duration ofthe 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 anevening 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 includesbarrier methods, hormones, or intrauterine devices (IUDs)

  • Life expectancy of 12 months or greater

  • Willing and able to provide informed consent

Exclusion

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 clinicallysignificant unstable medical condition

  • Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia orseizure 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 thesubject's inclusion in the study

Study Design

Total Participants: 217
Study Start date:
January 01, 2006
Estimated Completion Date:
May 31, 2007

Connect with a study center

  • Clinical Research Center

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • Gadsden Dialysis

    Gadsden, Alabama 35901
    United States

    Site Not Available

  • Holy Cross Renal Care

    Mission Hills, California 91345
    United States

    Site Not Available

  • Nephrology Educational Services and Research

    Tarzana, California 91356
    United States

    Site Not Available

  • Crystal Rivers Dialysis Center

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Outcomes Research International, Inc.

    Hudson, Florida 34667
    United States

    Site Not Available

  • Central Dialysis Center

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Atlanta Nephrology Referral Center

    Decatur, Georgia 30030
    United States

    Site Not Available

  • FMC Marietta

    Marietta, Georgia 30066
    United States

    Site Not Available

  • Horizon Healthcare Associates

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Indiana University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Ochsner Clinic Foundation, Nephrology Research

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Southwest Mississippi Nephrology, PLLC

    Brookhaven, Mississippi 39601
    United States

    Site Not Available

  • Nephrology Associates, P.C.

    Columbus, Mississippi 39705
    United States

    Site Not Available

  • Nephrology & Hypertension Associates, LTD

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Hypertension and Nephrology Associates

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • Davita

    Bronx, New York 10461
    United States

    Site Not Available

  • Winthrop University Dialysis Center

    Mineola, New York 11501
    United States

    Site Not Available

  • Kidney and Hypertension Center

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Renal Care Group

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Lewiston Dialysis Center

    Lewistown, Pennsylvania 17044
    United States

    Site Not Available

  • Medical Nephrology Associates

    Dyersburg, Tennessee 38024
    United States

    Site Not Available

  • Nephrology Associates, P.C.

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Renal Research Inc. at the Kidney Institute

    Houston, Texas 77054
    United States

    Site Not Available

  • Gambro Healthcare - Charlottesville

    Charlottesville, Virginia 22902
    United States

    Site Not Available

  • Clinical Research of Tidewater

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Virginia Commonwealth University, Division of Nephrology

    Richmond, Virginia 23298
    United States

    Site Not Available

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