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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

November 10, 2017
November 27, 2017
April 4, 2018
January 17, 2018
January 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03353298 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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
  • 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
  • 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.
  • Change in estimated GFR [ Time Frame: Nine months ]
    Change from baseline to 9 months in the allopurinol group compared to placebo in estimated GFR
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Renal Transplant Donor of Left Kidney
  • Renal Transplant Donor of Right Kidney
  • Drug: Allopurinol 300 mg
    Allopurinol oral tablets 300 mg given to participants once daily for 9 months
  • Drug: Placebo Oral Tablet
    placebo oral tablets given to participants once daily for 9 months
  • Active Comparator: Arm A
    Allopurinol 300 mg
    Intervention: Drug: Allopurinol 300 mg
  • Placebo Comparator: Arm B
    Placebo Oral tablets
    Intervention: Drug: Placebo Oral Tablet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Same as current
December 31, 2021
January 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Nina EB Langberg, MD +47 97100792 nlangb@ous-hf.no
Contact: Dag Olav Dahle, MD, PhD dagdah@ous-hf.no
Norway
 
 
NCT03353298
2017/397 C
2017-000666-30 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Dag Olav Dahle, Oslo University Hospital
Oslo University Hospital
  • South-Eastern Norway Regional Health Authority
  • University of Oslo
Principal Investigator: Dag Olav Dahle, MD, PhD Oslo University Hospital
Oslo University Hospital
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP