Lowering Uric Acid in Live Kidney Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2020-09-25

Brief Summary

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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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Detailed Description

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Conditions

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Renal Transplant Donor of Left Kidney Renal Transplant Donor of Right Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A

Allopurinol 300 mg

Group Type ACTIVE_COMPARATOR

Allopurinol 300 mg

Intervention Type DRUG

Allopurinol oral tablets 300 mg given to participants once daily for 9 months

Arm B

Placebo Oral tablets

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

placebo oral tablets given to participants once daily for 9 months

Interventions

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Allopurinol 300 mg

Allopurinol oral tablets 300 mg given to participants once daily for 9 months

Intervention Type DRUG

Placebo Oral Tablet

placebo oral tablets given to participants once daily for 9 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No