Overview

This trial is active, not recruiting.

Conditions type 1 diabetes, diabetic nephropathy
Treatments allopurinol, placebo
Phase phase 4
Sponsor Peter Rossing
Start date September 2014
End date August 2016
Trial size 30 participants
Trial identifier NCT02829177, 3004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
400 mg once daily, tablet treatment
allopurinol
(Placebo Comparator)
Identical tablet treatment
placebo

Primary Outcomes

Measure
Improved Albuminuria
time frame: 60 days

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Steno Diabetes Center.