Microalbuminuria and Allopurinol in Type 1 Diabetes

NCT ID: NCT02829177

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Allopurinol

400 mg once daily, tablet treatment

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Placebo

Identical tablet treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Allopurinol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter Rossing

OTHER

Sponsor Role lead

Responsible Party

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Peter Rossing

Senior Principal Investigator, Professor, Chief Physician, DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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3004

Identifier Type: -

Identifier Source: org_study_id

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