Microalbuminuria and Allopurinol in Type 1 Diabetes

The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.

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Key information

Conditions

Type 1 Diabetes Albuminuria Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Albuminuria (≥30 mg/g)
Uric Acid ≥ 0,265 mmol/l
GFR (glomerular filtration rate) > 40 ml/min/1.73m2

Exclusion criteria

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.

Treatment and study plan

Allopurinol

Drug

Placebo

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Peter Rossing

Other

Registry information

Official study title

A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria

Acronym: MIKAL

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Jul 12, 2016
Registry last updated: Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed