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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.
ClinicalTrials.gov Identifier: NCT00324376
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sevelamer hydrochloride Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Study Start Date : March 2003
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00324376


Locations
United States, Illinois
Renal Care Group
Olympia Fields, Illinois, United States
United States, Ohio
Kidney and Hypertension Center
Cincinnati, Ohio, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00324376     History of Changes
Other Study ID Numbers: GTC-68-209
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

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