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Trial record 1 of 1 for:    NCT00324376
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Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

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: NCT00324376
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 5, 2015
Information provided by:

Tracking Information
First Submitted Date  ICMJE May 9, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date March 5, 2015
Study Start Date  ICMJE March 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Official Title  ICMJE A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Brief Summary

A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

  1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
  2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Drug: Sevelamer hydrochloride
Study Arms  ICMJE Not Provided
Publications * Fishbane S, Delmez J, Suki WN, Hariachar SK, Heaton J, Chasan-Taber S, Plone MA, Moe S. A randomized, parallel, open-label study to compare once-daily sevelamer carbonate powder dosing with thrice-daily sevelamer hydrochloride tablet dosing in CKD patients on hemodialysis. Am J Kidney Dis. 2010 Feb;55(2):307-15. doi: 10.1053/j.ajkd.2009.10.051. Epub 2009 Dec 30.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 9, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • life expectancy of at least 12 months,
  • patients have received hemodialysis three times per week for 3 months or longer,
  • patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion Criteria:

  • active bowel obstruction,
  • dysphagia,
  • swallowing disorders,
  • 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,
  • any clinically significant unstable medical condition as judged 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 NCT00324376
Other Study ID Numbers  ICMJE GTC-68-209
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 2015

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