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Microalbuminuria and Allopurinol in Type 1 Diabetes (MIKAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829177
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Copenhagen

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : August 10, 2016
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829177


Locations
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Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Peter Rossing
More Information
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Responsible Party: Peter Rossing, Senior Principal Investigator, Professor, Chief Physician, DMSc, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT02829177    
Other Study ID Numbers: 3004
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Rossing, Steno Diabetes Center Copenhagen:
Type 1 diabetes
Diabetic nephropathy
Albuminuria
Allopurinol
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications
 Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs