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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: January 2006
Study Completion Date: May 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268957

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

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00268957     History of Changes
Other Study ID Numbers: GD3-199-301
Study First Received: December 22, 2005
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Chronic
Hemodialysis
Kidney
Hyperphosphatemia
Chronic kidney disease
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014