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Lowering Uric Acid in Live Kidney Donors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Lowering Uric Acid in Live Kidney Donors

A Randomized, Double-blind, Placebo-controlled, 9-month, Parallel Group Study of Allopurinol to Reduce Left Ventricular Mass in Living Kidney Donors (AL-DON)

NCT03353298•Oslo University Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+8 more criteria

Locations (1)

Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

January 17, 2018

Primary Completion Date

September 25, 2020

Completion Date

September 25, 2020

Last Updated

February 24, 2021

Enrollment

ACTUAL participants

Conditions

Renal Transplant Donor of Left KidneyRenal Transplant Donor of Right Kidney

Interventions

Allopurinol 300 mg

DRUG

Placebo Oral Tablet

DRUG

TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)

NCT02811835

Transplantation InfectionRenal Transplant Donor of Left Kidney

View study

TERMINATEDNA

Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy

NCT06458842

Narcotic UseRenal Transplant Donor of Left Kidney

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lowering Uric Acid in Live Kidney Donors

Inclusion Criteria

Exclusion Criteria

TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)

Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy

Fractures and Bone Disease in Living Kidney Donors