MIKAL: Microalbuminuria and Allopurinol in Type 1 Diabetes

Sponsor

Peter Rossing (Other)

Overall Status

Completed

CT.gov ID

NCT02829177

Collaborator

(none)

Enrollment

Location

Arms

36.6

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Diabetic Nephropathy	Drug: Allopurinol Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Aug 10, 2016

Actual Study Completion Date :

Sep 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allopurinol 400 mg once daily, tablet treatment	Drug: Allopurinol
Placebo Comparator: Placebo Identical tablet treatment	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Allopurinol

400 mg once daily, tablet treatment

Drug: Allopurinol

Placebo Comparator: Placebo

Identical tablet treatment

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.