Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)

• Status: Withdrawn
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 receiving maintenance hemodialysis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborator: Göteborg University
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Insulin; Sevelamer

Criteria

Inclusion Criteria:

• Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.

Exclusion Criteria:

• 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