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Trial record 1 of 1 for:    NCT00268957
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Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268957
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : March 19, 2014
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Chronic Renal Insufficiency End-Stage Renal Disease Drug: Sevelamer carbonate (Renvela®) Drug: Sevelamer hydrochloride (Renagel®) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268957

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Sponsors and Collaborators
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
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Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00268957    
Other Study ID Numbers: GD3-199-301
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by Sanofi:
Chronic kidney disease
Chronic Renal Insufficiency
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action