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CompletedNCT00268957Updated Mar 19, 2014

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

A Phase 3 interventional study of Sevelamer carbonate (Renvela®) and Sevelamer hydrochloride (Renagel®) in Kidney Diseases, Chronic Renal Insufficiency and End-Stage Renal Disease, sponsored by Genzyme, a Sanofi Company. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.

Sponsored by Genzyme, a Sanofi Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
217
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Kidney Diseases
  • Chronic Renal Insufficiency
  • End-Stage Renal Disease

Keywords

  • Chronic
  • Hemodialysis
  • Kidney
  • Hyperphosphatemia
  • Chronic kidney disease
  • Chronic Renal Insufficiency
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 217 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
217 participants (actual)

Study arms

  • Experimental
    1

    sevelamer carbonate powder

    Drug: Sevelamer carbonate (Renvela®)

  • Active comparator
    2

    Sevelamer hydrochloride

    Drug: Sevelamer hydrochloride (Renagel®)

Interventions

  • DrugSevelamer carbonate (Renvela®)

    sevelamer carbonate powder dosed once per day with largest meal

  • DrugSevelamer hydrochloride (Renagel®)

    Sevelamer hydrochloride tablets dosed three times a day with meals

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

07

Study locations

29 sites
  • Clinical Research Center
    Birmingham, Alabama 35213, United States
  • Gadsden Dialysis
    Gadsden, Alabama 35901, United States
  • Holy Cross Renal Care
    Mission Hills, California 91345, United States
  • Nephrology Educational Services and Research
    Tarzana, California 91356, United States
  • Crystal Rivers Dialysis Center
    Crystal River, Florida 34429, United States
  • Outcomes Research International, Inc.
    Hudson, Florida 34667, United States
  • Central Dialysis Center
    Atlanta, Georgia 30329, United States
  • Atlanta Nephrology Referral Center
    Decatur, Georgia 30030, United States
  • FMC Marietta
    Marietta, Georgia 30066, United States
  • Horizon Healthcare Associates
    Flossmoor, Illinois 60422, United States
  • Indiana University Hospital
    Indianapolis, Indiana 46202, United States
  • Ochsner Clinic Foundation, Nephrology Research
    New Orleans, Louisiana 70121, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Southwest Mississippi Nephrology, PLLC
    Brookhaven, Mississippi 39601, United States
  • Nephrology Associates, P.C.
    Columbus, Mississippi 39705, United States
  • Nephrology & Hypertension Associates, LTD
    Tupelo, Mississippi 38801, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • Hypertension and Nephrology Associates
    Eatontown, New Jersey 07724, United States
  • Davita
    Bronx, New York 10461, United States
  • Winthrop University Dialysis Center
    Mineola, New York 11501, United States
  • Kidney and Hypertension Center
    Cincinnati, Ohio 45220, United States
  • Renal Care Group
    Cleveland, Ohio 44109, United States
  • Lewiston Dialysis Center
    Lewistown, Pennsylvania 17044, United States
  • Medical Nephrology Associates
    Dyersburg, Tennessee 38024, United States
  • Nephrology Associates, P.C.
    Nashville, Tennessee 37205, United States
  • Renal Research Inc. at the Kidney Institute
    Houston, Texas 77054, United States
  • Gambro Healthcare - Charlottesville
    Charlottesville, Virginia 22902, United States
  • Clinical Research of Tidewater
    Norfolk, Virginia 23507, United States
  • Virginia Commonwealth University, Division of Nephrology
    Richmond, Virginia 23298, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00268957
Lead sponsor
Genzyme, a Sanofi Company
First posted
Dec 23, 2005
Start date
Jan 2006
Primary completion
Mar 2007
Completion
May 2007
Last update
Mar 19, 2014

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

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