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Microalbuminuria and Allopurinol in Type 1 Diabetes (MIKAL)

Primary Purpose

Type 1 Diabetes, Diabetic Nephropathy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
Peter Rossing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Steno Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

400 mg once daily, tablet treatment

Identical tablet treatment

Outcomes

Primary Outcome Measures

Improved Albuminuria
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.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2015
Last Updated
September 6, 2018
Sponsor
Peter Rossing
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1. Study Identification

Unique Protocol Identification Number
NCT02829177
Brief Title
Microalbuminuria and Allopurinol in Type 1 Diabetes
Acronym
MIKAL
Official Title
A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 10, 2016 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Rossing

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Diabetic Nephropathy
Keywords
Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Description
400 mg once daily, tablet treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical tablet treatment
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Improved Albuminuria
Description
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Microalbuminuria and Allopurinol in Type 1 Diabetes

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