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Renal Transplant Donor of Left KidneyPhase 2AL-DONNCT03353298

Lowering Uric Acid in Live Kidney Donors

A Phase 2 study testing Allopurinol 300 mg in people with Renal Transplant Donor of Left Kidney and Renal Transplant Donor of Right Kidney, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Allopurinol 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteNorway
Study dates
17 Jan 2018to 25 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

Official 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)

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.

Being tested
Allopurinol 300 mg, Placebo Oral Tablet
Keywords
Uric acid, Left ventricular mass, Nephrectomy, Allopurinol, Magnetic resonance imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allopurinol 300 mgDrug

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

  • Placebo Oral TabletDrug

    placebo oral tablets given to participants once daily for 9 months

Study groups in NCT03353298
Study groupRoleWhat they receive
Arm AActive comparatorAllopurinol 300 mg
Receives: Drug: Allopurinol 300 mg
Arm BPlacebo comparatorPlacebo Oral tablets
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in left ventricular mass

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

    Measured: Nine months

Secondary outcomes (6)

  1. Change in blood pressure

    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.

    Measured: Nine months

  2. Estimated insulin sensitivity, metabolic clearance rate of glucose

    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.

    Measured: Nine months

  3. Number of antihypertensive medications

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

    Measured: Nine months

  4. Doses of antihypertensive medications

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

    Measured: Nine months

  5. Change in urinary albumin excretion

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

    Measured: Nine months

  6. Change in estimated GFR

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

    Measured: Nine months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start17 Jan 2018
  3. Primary completion25 Sep 2020
  4. Study completion25 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353298
Sponsor's protocol ID
2017/397 C
Other IDs
2017-000666-30, 2017
Acronym
AL-DON
Status last verified
Feb 2021
First submitted
10 Nov 2017
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608.

    PubMed 26754643

  • Kao MP, Ang DS, Gandy SJ, Nadir MA, Houston JG, Lang CC, Struthers AD. Allopurinol benefits left ventricular mass and endothelial dysfunction in chronic kidney disease. J Am Soc Nephrol. 2011 Jul;22(7):1382-9. doi: 10.1681/ASN.2010111185. Epub 2011 Jun 30.

    PubMed 21719783

  • Altmann U, Boger CA, Farkas S, Mack M, Luchner A, Hamer OW, Zeman F, Debl K, Fellner C, Jungbauer C, Banas B, Buchner S. Effects of Reduced Kidney Function Because of Living Kidney Donation on Left Ventricular Mass. Hypertension. 2017 Feb;69(2):297-303. doi: 10.1161/HYPERTENSIONAHA.116.08175. Epub 2017 Jan 3.

    PubMed 28049698

  • Rekhraj S, Gandy SJ, Szwejkowski BR, Nadir MA, Noman A, Houston JG, Lang CC, George J, Struthers AD. High-dose allopurinol reduces left ventricular mass in patients with ischemic heart disease. J Am Coll Cardiol. 2013 Mar 5;61(9):926-32. doi: 10.1016/j.jacc.2012.09.066.

    PubMed 23449426

  • Szwejkowski BR, Gandy SJ, Rekhraj S, Houston JG, Lang CC, Morris AD, George J, Struthers AD. Allopurinol reduces left ventricular mass in patients with type 2 diabetes and left ventricular hypertrophy. J Am Coll Cardiol. 2013 Dec 17;62(24):2284-93. doi: 10.1016/j.jacc.2013.07.074. Epub 2013 Aug 28.

    PubMed 23994420

  • Langberg NE, Jenssen TG, Hopp E, Haugen A, Asberg A, Birkeland KI, Hartmann A, Dahle DO. A Randomized Controlled Trial to Evaluate Allopurinol Versus Placebo on Left Ventricular Mass in Living Kidney Donors. Kidney360. 2026 Oct 1;7(10):2363-2371. doi: 10.34067/KID.0000001313. Epub 2026 Aug 3.

    PubMed 42545761

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allopurinol 300 mg in people with Renal Transplant Donor of Left Kidney and Renal Transplant Donor of Right Kidney, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in left ventricular mass (time frame: Nine months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353298, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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