Microalbuminuria and Allopurinol in Type 1 Diabetes (MIKAL)
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|ClinicalTrials.gov Identifier: NCT02829177|
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : September 10, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Diabetic Nephropathy||Drug: Allopurinol Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 10, 2016|
|Actual Study Completion Date :||September 20, 2017|
Active Comparator: Allopurinol
400 mg once daily, tablet treatment
Placebo Comparator: Placebo
Identical tablet treatment
- Improved Albuminuria [ Time Frame: 60 days ]Improvement of albuminuria will be evaluated by the collection of 24h urin collection with the measure of 24h albumine excretion rate and the measurements will be compared for the two treatment arm for each participant.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Albuminuria (≥30 mg/g)
- Uric Acid ≥ 0,265 mmol/l
- GFR (glomerular filtration rate) > 40 ml/min/1.73m2
- History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy.
- Recurrent renal calculi.
- Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
- Known allergy to xanthine-oxidase inhibitors.
- Renal transplant.
- Non-diabetic kidney disease.
- Home, 24h og clinical BP>180 or Diastolic BP >130 mmHg at screening.
- Cancer treatment within two years before screening.
- History of hepatitis B or C.
- History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection.
- History of alcohol or drug abuse.
- Breastfeeding or pregnancy or unwillingness to be on contraception throughout the trial.
- Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
- Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
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): NCT02829177
|Steno Diabetes Center|
|Gentofte, Denmark, 2820|
|Responsible Party:||Peter Rossing, Senior Principal Investigator, Professor, Chief Physician, DMSc, Steno Diabetes Center Copenhagen|
|Other Study ID Numbers:||
|First Posted:||July 12, 2016 Key Record Dates|
|Last Update Posted:||September 10, 2018|
|Last Verified:||September 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Type 1 diabetes
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Free Radical Scavengers
Physiological Effects of Drugs