Status:
COMPLETED
Lowering Uric Acid in Live Kidney Donors
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
University of Oslo
Conditions:
Renal Transplant Donor of Left Kidney
Renal Transplant Donor of Right Kidney
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03353298
Start Date
January 17 2018
End Date
September 25 2020
Last Update
February 24 2021
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway