Microalbuminuria and Allopurinol in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— MIKAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829177
• Other study ID #: 3004
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: September 20, 2017

Study information

• Verified date: September 2018
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2017
• Est. primary completion date: August 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 1 Diabetes

Intervention

Drug:
• Allopurinol

• Placebo

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Peter Rossing

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 days