A Randomized, Double-blind, Placebo-controlled, 9-month, Parallel Group Study of Allopurinol to Reduce Left Ventricular Mass in Living Kidney Donors (AL-DON)
| Registry | NCT03353298, acronym AL-DON |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 71 (Actual) |
| Sponsor | Oslo University Hospital (Other); collaborators: South-Eastern Norway Regional Health Authority, University of Oslo |
| Conditions | Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney |
| Interventions | Allopurinol 300 mg, Placebo Oral Tablet (Drug) |
| Dates | start 2018-01-17, primary completion 2020-09-25, completion 2020-09-25, first posted 2017-11-27, last updated 2021-02-24 |
| Locations | 1 site in Norway |
Related Papers Related Patents Related Grants Related Experts
All trials for Renal Transplant Donor of Left Kidney All trials for Renal Transplant Donor of Right Kidney All trials of Allopurinol 300 mg All trials of Placebo Oral Tablet
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm A | Active comparator | Drug: Allopurinol 300 mg | Allopurinol 300 mg |
| Arm B | Placebo comparator | Drug: Placebo Oral Tablet | Placebo Oral tablets |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Kidney donor ≥ 6 months after donor nephrectomy 2. Donor nephrectomy undertaken in Norway 3. Male or female subject ≥ 18 years old 4. eGFR >30 ml/min/1.73 m2 5. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: 1. Adverse reactions to allopurinol or other xanthine oxidase inhibitors 2. Use of uric acid lowering therapy within 3 months 3. History of gout, xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy 4. History of renal calculi 5. History of coronary heart disease 6. Heart failure with left ventricular ejection fraction <45% 7. History of significant (i.e. non-physiological) cardiac valvular stenosis or insufficiency 8. History of clinically significant hepatic disease including hepatitis B or C and/or ALAT (SGPT) above the upper reference limit at screening. 9. History of HIV or AIDS 10. Severe systemic infections, current or within the last 6 months 11. History of malignancy other than localized basal cell carcinoma of the skin, treated or untreated, within the past 5 years. 12. Other life-threatening diseases 13. Haemoglobin concentration < 11 g/dL(males), <10 g/dL (females); white blood cell (WBC) count < 3.5 * 10\^9/L; platelet count <50 *10\^9/L at screening 14. Use of the following medications at or within 14 days before the screening visit: azathioprine, mercaptopurine, vidarabin, chlorpropamide, warfarin, tamoxifen, theophylline, amoxicillin/ampicillin, cyclophosphamide, doksorubicin, bleomycin, prokarbazin, cyclosporine, didanosine. 15. Contraindications to MRI, including: Magnetic intracranial clips. Metal fragments in orbita. Cochlea (ear) implant. Neurostimulator. Pacemaker/ICD or remaining pacemaker electrodes. Harrington rods in thorax. Claustrophobia. Unable to lie supine. 16. Pregnant or nursing (lactating) women 17. Fertile women, unless they are using effective contraception during dosing of study treatment 18. Any reason why, in the opinion of the investigator, the patient should not participate.
| Facility | City | Country | Status |
|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
NIH grants: 2017