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

Insulin Resistance Clinical Trial

— SIR  

Official title:

Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00837655
• Other study ID #: SIR_CT_CLINTEC_01
• Status: Withdrawn
• Phase: N/A
• First received: January 29, 2009
• Last updated: September 25, 2012
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2009
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hyperphosphatemia
• Insulin Resistance
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Sevelamer
sevelamer tablets, 800 mg (Renagel(r), Genzyme Inc). The initial daily dose of sevelamer will be 2400 mg (800 mg x 3). After the first week of treatment the dose will be increased to 4800 mg. If treatment with sevelamer is well tolerated and if a phosphate concentration of <1.8 mmol/l is not obtained, the dose may be increased further. The maximum daily dose of sevelamer will be 9600 mg. If a patient experiences side effects, the dose of sevelamer will be reduced to the highest acceptable dose, and, if a phosphate concentration of <1.8 mmol/l is not obtained, the treatment will be supplemented with calcium carbonate in a dose tolerated by the patient.
• Calcium carbonate
Calcium carbonate tablets, 250 mg (Kalcidon, Abigo AB). Calcium carbonate will be prescribed at the dose given prior to the washout period. The dose will be adjusted weekly to obtain a serum phosphate concentration <1.8 mmol/l.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Soonthornpun S, Setasuban W, Thamprasit A, Chayanunnukul W, Rattarasarn C, Geater A. Novel insulin sensitivity index derived from oral glucose tolerance test. J Clin Endocrinol Metab. 2003 Mar;88(3):1019-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.		Week 12	No
Secondary	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	Yes
Secondary	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	No
Secondary	Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)		Week 12	No
Secondary	Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.		Weekly until end of study	Yes