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

Not Applicable

Withdrawn

• Conditions: Kidney Failure, Chronic; End-Stage Renal Disease; Insulin Resistance; Hyperphosphatemia
• Interventions: Drug: Sevelamer; Drug: Calcium carbonate

• Registration Number: NCT00837655
• Lead Sponsor: Karolinska Institutet

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 receiving maintenance hemodialysis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sevelamer	Sevelamer intervention
2	Calcium carbonate	Calcium carbonate

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.	Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).	Week 12
Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)	Week 12
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)	Week 12
Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.	Weekly until end of study

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden