Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
NCT ID: NCT00837655
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Sevelamer intervention
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.
2
Calcium carbonate
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Karolinska institutet
Principal Investigators
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Anders Alvestrand, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Jonas Axelsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Countries
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References
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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. doi: 10.1210/jc.2002-021127.
Other Identifiers
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SIR_CT_CLINTEC_01
Identifier Type: -
Identifier Source: org_study_id