Microalbuminuria and Allopurinol in Type 1 Diabetes (MIKAL)

September 6, 2018 updated by: Peter Rossing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Rossing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 10, 2016

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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