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

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ClinicalTrials.gov Identifier: NCT03353298
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Dag Olav Dahle, Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Renal Transplant Donor of Left Kidney Renal Transplant Donor of Right Kidney Drug: Allopurinol 300 mg Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353298


Contacts
Contact: Nina EB Langberg, MD +47 97100792 nlangb@ous-hf.no
Contact: Dag Olav Dahle, MD, PhD dagdah@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: NE Langberg       nlangb@ous-hf.no   
Contact: DO Dahle       dagdah@ous-hf.no   
Principal Investigator: DO Dahle         
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
University of Oslo
Investigators
Principal Investigator: Dag Olav Dahle, MD, PhD Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Dag Olav Dahle, Oslo University Hospital:

Publications:
Responsible Party: Dag Olav Dahle, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03353298     History of Changes
Other Study ID Numbers: 2017/397 C
2017-000666-30 ( EudraCT Number )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dag Olav Dahle, Oslo University Hospital:
Uric acid
Left ventricular mass
Nephrectomy
Allopurinol
Magnetic resonance imaging

Additional relevant MeSH terms:
Allopurinol
Uric Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs