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Completed

NCT Number: NCT03353298

Lowering Uric Acid in Live Kidney Donors

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney donor ≥ 6 months after donor nephrectomy
  • Donor nephrectomy undertaken in Norway
  • Male or female subject ≥ 18 years old
  • eGFR >30 ml/min/1.73 m2
  • 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

  • Adverse reactions to allopurinol or other xanthine oxidase inhibitors
  • Use of uric acid lowering therapy within 3 months
  • History of gout, xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy
  • History of renal calculi
  • History of coronary heart disease
  • Heart failure with left ventricular ejection fraction <45%
  • History of significant (i.e. non-physiological) cardiac valvular stenosis or insufficiency
  • History of clinically significant hepatic disease including hepatitis B or C and/or ALAT (SGPT) above the upper reference limit at screening.
  • History of HIV or AIDS
  • Severe systemic infections, current or within the last 6 months
  • History of malignancy other than localized basal cell carcinoma of the skin, treated or untreated, within the past 5 years.
  • Other life-threatening diseases
  • 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
  • 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.
  • 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.
  • Pregnant or nursing (lactating) women
  • Fertile women, unless they are using effective contraception during dosing of study treatment
  • Any reason why, in the opinion of the investigator, the patient should not participate.

Treatment and study plan

Allopurinol 300 MG

Drug

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

Placebo oral tablet

Drug

placebo oral tablets given to participants once daily for 9 months

Primary outcomes

  1. Change in left ventricular mass

    Time frame: Nine months

    Measured change in left ventricular mass using Cardiac MRI, comparing from baseline to 9 months of treatment With allopurinol compared to placebo.

Secondary outcomes

  1. Change in blood pressure

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in systolic and diastolic ambulatory blood pressure, systolic and diastolic Office blood pressure.

  2. Estimated insulin sensitivity, metabolic clearance rate of glucose

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in insulin sensitivity using an orgal glucose tolerance test to measure estimated metabolic clearance rate of glucose, insulin sensitivity, firth-phase insulin release and second-phase insulin release.

  3. Number of antihypertensive medications

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in number of antihypertensive medications

  4. Doses of antihypertensive medications

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in doses of antihypertensive medications

  5. Change in urinary albumin excretion

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in urinary albumin excretion by measuring urinary albumin/creatinine ratio.

  6. Change in estimated GFR

    Time frame: Nine months

    Change from baseline to 9 months in the allopurinol group compared to placebo in estimated GFR

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority
  • University of Oslo

Registry information

Official study title

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

Acronym: AL-DON

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2017
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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