Back to resultsStudy to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sevelamer hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility 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.
Sites / Locations
- Renal Care Group
- Kidney and Hypertension Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00324376
Brief Title
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Official Title
A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. 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:
sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Renal Care Group
City
Olympia Fields
State/Province
Illinois
Country
United States
Facility Name
Kidney and Hypertension Center
City
Cincinnati
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20042256
Citation
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.
Results Reference
derived
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Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
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