Status:
WITHDRAWN
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Göteborg University
Conditions:
Kidney Failure, Chronic
End-Stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receivi...
Eligibility Criteria
Inclusion
- Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for \>3 months.
Exclusion
- Diabetes mellitus
- Treatment with sevelamer within 3 months prior to enrollment
- Acute, clinically significant inflammation within 1 month prior to enrollment
- Pregnancy or breast-feeding
- Clinically significant obstipation or bowel obstruction
- Discontinuation of previous sevelamer treatment because of side effects
- Expected time in HD \< 1 year
- Unwillingness to undergo the investigations and follow-up required in the the protocol
- Patients who have received any investigational drug within 1 month prior to enrolment
- Participation in another study, which may interfere with the present study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00837655
Start Date
January 1 2009
End Date
June 1 2011
Last Update
September 26 2012
Active Locations (2)
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1
Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden, 413 45
2
Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 14186