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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00268957
First received: December 22, 2005
Last updated: March 17, 2014
Last verified: March 2014

December 22, 2005
March 17, 2014
January 2006
March 2007   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed 3x a day with meals on the control of serum phosphorus.
  • Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals.
Complete list of historical versions of study NCT00268957 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Diseases
  • Chronic Renal Insufficiency
  • End-Stage Renal Disease
  • Drug: Sevelamer carbonate (Renvela®)
    sevelamer carbonate powder dosed once per day with largest meal
  • Drug: Sevelamer hydrochloride (Renagel®)
    Sevelamer hydrochloride tablets dosed three times a day with meals
  • Experimental: 1
    sevelamer carbonate powder
    Intervention: Drug: Sevelamer carbonate (Renvela®)
  • Active Comparator: 2
    Sevelamer hydrochloride
    Intervention: Drug: Sevelamer hydrochloride (Renagel®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
May 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00268957
GD3-199-301
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP