Lowering Uric Acid in Live Kidney Donors (AL-DON)

University of Oslo (UIO)

Status and phase: Completed; Phase 2

Conditions: Renal Transplant Donor of Right Kidney; Renal Transplant Donor of Left Kidney

Treatments: Drug: Placebo Oral Tablet; Drug: Allopurinol 300 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03353298

2017/397 C

2017-000666-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

Arm A

Active Comparator group

Description:

Allopurinol 300 mg

Treatment:

Drug: Allopurinol 300 mg

Arm B

Placebo Comparator group

Description:

Placebo Oral tablets

Treatment:

Drug: Placebo Oral Tablet