Microalbuminuria and Allopurinol in Type 1 Diabetes

NCT02829177 | Completed Phase 4

• 1 other identifier: 3004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Diabetic Nephropathy

Keywords

Type 1 diabetes; Diabetic nephropathy; Albuminuria; Allopurinol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

400 mg once daily, tablet treatment

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Identical tablet treatment

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Albuminuria (≥30 mg/g)
• Uric Acid ≥ 0,265 mmol/l
• GFR (glomerular filtration rate) \> 40 ml/min/1.73m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter Rossing: lead

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Nephropathies; Albuminuria

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Principal Investigator, Professor, Chief Physician, DMSc

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: July 12, 2016
• Study Start: September 1, 2014
• Primary Completion: August 10, 2016
• Study Completion: September 20, 2017
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)