- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837655
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD) (SIR)
September 25, 2012 updated by: Karolinska Institutet
Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
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 Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gothenburg, Sweden, 413 45
- Sahlgrenska University Hospital
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Stockholm, Sweden, 14186
- Karolinska University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Sevelamer intervention
|
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 Names:
|
Active Comparator: 2
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
Time Frame: Week 12
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Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Week 12
|
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
Time Frame: Week 12
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Week 12
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Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
Time Frame: Weekly until end of study
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Weekly until end of study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Alvestrand, MD PhD, Karolinska Institutet
- Principal Investigator: Jonas Axelsson, MD, PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Estimate)
September 26, 2012
Last Update Submitted That Met QC Criteria
September 25, 2012
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Hyperinsulinism
- Renal Insufficiency, Chronic
- Phosphorus Metabolism Disorders
- Kidney Diseases
- Kidney Failure, Chronic
- Renal Insufficiency
- Insulin Resistance
- Hyperphosphatemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Calcium-Regulating Hormones and Agents
- Chelating Agents
- Sequestering Agents
- Antacids
- Calcium
- Sevelamer
- Calcium Carbonate
Other Study ID Numbers
- SIR_CT_CLINTEC_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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