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Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

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ClinicalTrials.gov Identifier: NCT00440648
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : March 19, 2014
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 24, 2007
First Posted Date  ICMJE February 27, 2007
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
  • Safety-evaluated on the basis of adverse events (reported and/or observed) [ Time Frame: 16 weeks ]
  • changes in laboratory parameters, vital signs [ Time Frame: 16 weeks ]
  • note: clinically significant changes in physical examination were recorded and evaluated as adverse events [ Time Frame: 16 weeks ]
  • Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period [ Time Frame: 16 weeks ]
  • Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2007)
  • Safety-evaluated on the basis of adverse events (reported and/or observed)
  • changes in laboratory parameters, vital signs
  • note: clinically significant changes in physical examination were recorded and evaluated as adverse events
  • Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
  • Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
Change History Complete list of historical versions of study NCT00440648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Official Title  ICMJE A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Brief Summary This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
Detailed Description The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: sevelamer carbonate, sevelamer hydrochloride
    Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
  • Drug: sevelamer hydrochloride, sevelamer carbonate
    Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Study Arms  ICMJE
  • 1
    sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
    Intervention: Drug: sevelamer carbonate, sevelamer hydrochloride
  • 2
    sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
    Intervention: Drug: sevelamer hydrochloride, sevelamer carbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2007)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patient had received hemodialysis three times per week for 3 months or longer;
  • patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.

Exclusion Criteria:

  • if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
  • active ethanol or drug abuse (excluding tobacco);
  • need for antidysrhythmic or antiseizure medications used to control these conditions;
  • poorly controlled diabetes mellitus or hypertension;
  • active vasculitis;
  • active malignancy other than basal-cell carcinoma;
  • HIV infection; or
  • any clinically significant unstable medical condition as judge by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00440648
Other Study ID Numbers  ICMJE GD3-163-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Monitor, Genzyme Corporation
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date March 2014

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