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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sevelamer intervention |
|
| 2 | Active Comparator | Calcium carbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT. | Week 12 |
| Measure | Description | 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Alvestrand, MD PhD | Karolinska Institutet | Principal Investigator |
| Jonas Axelsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Gothenburg | 413 45 | Sweden | ||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12629079 | Background | 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. |
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|
| Calcium carbonate | Drug | 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. |
|
| Week 12 |
| Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin) | Week 12 |
| Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments. | Weekly until end of study |
| Stockholm |
| Stockholm County |
| 14186 |
| Sweden |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007333 | Insulin Resistance |
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010760 | Phosphorus Metabolism Disorders |
| D006943 | Hyperglycemia |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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