Lowering Uric Acid in Live Kidney Donors

• Status: Completed
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority; University of Oslo
• Treatments: Allopurinol; Uric Acid

Criteria

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.