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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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
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
|Contact: Nina EB Langberg, MD||+47 firstname.lastname@example.org|
|Contact: Dag Olav Dahle, MD, PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Contact: NE Langberg firstname.lastname@example.org|
|Contact: DO Dahle email@example.com|
|Principal Investigator: DO Dahle|
|Principal Investigator:||Dag Olav Dahle, MD, PhD||Oslo University Hospital|