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

Karolinska Institutet

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

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

Interventions

SevelamerDRUG

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 carbonateDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Sahlgrenska University Hospital

Gothenburg, Gothenburg, Sweden

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).

Time frame: 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)

Time frame: Week 12

Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)

Time frame: Week 12

Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.

Time frame: Weekly until end of study

Data from ClinicalTrials.gov

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