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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837655
Recruitment Status : Withdrawn (PI retired)
First Posted : February 5, 2009
Last Update Posted : September 26, 2012
Göteborg University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic End-Stage Renal Disease Insulin Resistance Hyperphosphatemia Drug: Sevelamer Drug: Calcium carbonate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
Study Start Date : January 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Sevelamer 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.
Other Name: Renagel

Active Comparator: 2
Calcium carbonate
Drug: 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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin) [ Time Frame: Week 12 ]
  4. Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments. [ Time Frame: Weekly until end of study ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837655

Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Göteborg University
Principal Investigator: Anders Alvestrand, MD PhD Karolinska Institutet
Principal Investigator: Jonas Axelsson, MD, PhD Karolinska Institutet

Responsible Party: Anders Alvestrand, Professor, Karolinska institutet Identifier: NCT00837655     History of Changes
Other Study ID Numbers: SIR_CT_CLINTEC_01
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: January 2009

Keywords provided by Karolinska Institutet:
Chronic kidney disease
End-stage renal disease
phosphate binder
insulin resistance
glucose intolerance

Additional relevant MeSH terms:
Kidney Failure, Chronic
Insulin Resistance
Kidney Diseases
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Phosphorus Metabolism Disorders
Calcium, Dietary
Calcium Carbonate
Hypoglycemic Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Chelating Agents
Sequestering Agents