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

February 23, 2021 updated by: Dag Olav Dahle, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Allopurinol 300 mg
Drug: Allopurinol 300 mg
Allopurinol oral tablets 300 mg given to participants once daily for 9 months
Placebo Comparator: Arm B
Placebo Oral tablets
Drug: Placebo Oral Tablet
placebo oral tablets given to participants once daily for 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Nine months
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.
Nine months
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
Nine months
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
Nine months
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.
Nine months
Change in estimated GFR
Time Frame: Nine months
Change from baseline to 9 months in the allopurinol group compared to placebo in estimated GFR
Nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Dag Olav Dahle, MD, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

September 25, 2020

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/397 C
  • 2017-000666-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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