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

This study has been withdrawn prior to enrollment.
(PI retired)
Sponsor:
Collaborator:
Göteborg University
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00837655
First received: January 29, 2009
Last updated: September 25, 2012
Last verified: January 2009
  Purpose

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 Intervention
Kidney Failure, Chronic
End-Stage Renal Disease
Insulin Resistance
Hyperphosphatemia
Drug: Sevelamer
Drug: Calcium carbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments. [ Time Frame: Weekly until end of study ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837655

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

Publications:
Responsible Party: Anders Alvestrand, Professor, Karolinska institutet
ClinicalTrials.gov Identifier: NCT00837655     History of Changes
Other Study ID Numbers: SIR_CT_CLINTEC_01
Study First Received: January 29, 2009
Last Updated: September 25, 2012
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Hyperphosphatemia
Insulin Resistance
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Phosphorus Metabolism Disorders
Renal Insufficiency, Chronic
Urologic Diseases
Calcium Carbonate
Insulin
Sevelamer
Antacids
Chelating Agents
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents

ClinicalTrials.gov processed this record on October 23, 2014