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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000666-30 | EudraCT Number |
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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
| University of Oslo | OTHER |
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Recently there was described an increase in left ventricular mass after kidney donation. It is uncertain whether this is reversible or not. Allopurinol lowers uric acid in the blood and is normally indicated for gout, but studies have showed that it also can reduce the thickness of the left ventricle of the heart in people with heart- and kidney disease.
The investigators wish to give allopurinol or placebo to kidney donors based on randomization and investigate if this has the same effect on kidney donors. The investigators are assessing this by performing a cardiac MRI at baseline and after 9 months of treatment. In addition the investigators wish to see if allopurinol can have beneficial effects on blood pressure and insulin sensitivity as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Allopurinol 300 mg |
|
| Arm B | Placebo Comparator | Placebo Oral tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol 300 mg | Drug | Allopurinol oral tablets 300 mg given to participants once daily for 9 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular mass | Measured change in left ventricular mass using Cardiac MRI, comparing from baseline to 9 months of treatment With allopurinol compared to placebo. | Nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Change from baseline to 9 months in the allopurinol group compared to placebo in systolic and diastolic ambulatory blood pressure, systolic and diastolic Office blood pressure. | Nine months |
| Estimated insulin sensitivity, metabolic clearance rate of glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Olav Dahle, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26754643 | Background | Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608. | |
| 21719783 | Background | Kao MP, Ang DS, Gandy SJ, Nadir MA, Houston JG, Lang CC, Struthers AD. Allopurinol benefits left ventricular mass and endothelial dysfunction in chronic kidney disease. J Am Soc Nephrol. 2011 Jul;22(7):1382-9. doi: 10.1681/ASN.2010111185. Epub 2011 Jun 30. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | Nov 16, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Oral Tablet | Drug | placebo oral tablets given to participants once daily for 9 months |
|
Change from baseline to 9 months in the allopurinol group compared to placebo in insulin sensitivity using an orgal glucose tolerance test to measure estimated metabolic clearance rate of glucose, insulin sensitivity, firth-phase insulin release and second-phase insulin release. |
| Nine months |
| Number of antihypertensive medications | Change from baseline to 9 months in the allopurinol group compared to placebo in number of antihypertensive medications | Nine months |
| Doses of antihypertensive medications | Change from baseline to 9 months in the allopurinol group compared to placebo in doses of antihypertensive medications | Nine months |
| Change in urinary albumin excretion | Change from baseline to 9 months in the allopurinol group compared to placebo in urinary albumin excretion by measuring urinary albumin/creatinine ratio. | Nine months |
| Change in estimated GFR | Change from baseline to 9 months in the allopurinol group compared to placebo in estimated GFR | Nine months |
| 28049698 | Background | Altmann U, Boger CA, Farkas S, Mack M, Luchner A, Hamer OW, Zeman F, Debl K, Fellner C, Jungbauer C, Banas B, Buchner S. Effects of Reduced Kidney Function Because of Living Kidney Donation on Left Ventricular Mass. Hypertension. 2017 Feb;69(2):297-303. doi: 10.1161/HYPERTENSIONAHA.116.08175. Epub 2017 Jan 3. |
| 23449426 | Background | Rekhraj S, Gandy SJ, Szwejkowski BR, Nadir MA, Noman A, Houston JG, Lang CC, George J, Struthers AD. High-dose allopurinol reduces left ventricular mass in patients with ischemic heart disease. J Am Coll Cardiol. 2013 Mar 5;61(9):926-32. doi: 10.1016/j.jacc.2012.09.066. |
| 23994420 | Background | Szwejkowski BR, Gandy SJ, Rekhraj S, Houston JG, Lang CC, Morris AD, George J, Struthers AD. Allopurinol reduces left ventricular mass in patients with type 2 diabetes and left ventricular hypertrophy. J Am Coll Cardiol. 2013 Dec 17;62(24):2284-93. doi: 10.1016/j.jacc.2013.07.074. Epub 2013 Aug 28. |