Microalbuminuria and Allopurinol in Type 1 Diabetes

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02829177

Acronym

MIKAL

Enrollment

Registered

2016-07-12

Start date

2014-09-30

Completion date

2017-09-20

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Type 1 Diabetes

Keywords

Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol

Brief summary

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.

Interventions

DRUGAllopurinol

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Improved Albuminuria	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026