Study of Allopurinol to prevent loss of kidney function in type 1 diabetes

Phase 1

Conditions: Type 1 diabetes and microalbuminuria.
MedDRA version: 18.0Level: LLTClassification code 10037827Term: Raised serum uric acidSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-001786-26-DK

Lead Sponsor: Steno Diabetes Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Male or female type 1 diabetes between 18 and 75 years of age, inclusive.
History or presence of microalbuminuria.
Estimated GFR > 50 ml/min/1.73 m2
Serum UA = 0,265 mmol/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Known allergy to xanthine-oxidase inhibitors or allopurinol.
Already in Allopurinol treatment or indications for uric acid lowering therapy.
Use of urate-lowering agents within 3 months before screening.
Renal Calculi.
Current use of azathioprine, 6-mercaptopurine, didanosine, warfarin, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
Breastfeeding, pregnancy or unwillingness to be on contraception if still fertile.
Non-diabetic kidney disease. HIV or hepatitis.
Poor mental function or any other reason to expect patient difficulty incomplying with the requirements of the study. Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
Ongoing alcohol or drug abuse.
SBP > 180 or DBP > 110 mg

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether lowering serum uric acid by means of allopurinol early in the course of kidney disease may be effective in slowing the decline of renal function in T1D patients.;Secondary Objective: To evaluate if the albuminuria lowering effect correlates with changes in uric acid, 24 hour blood pressure, kidney function, HbA1c and inflammatory biomarkers for CVD. ;Primary end point(s): Changes in albuminuria (UAE): we expect a fall in albuminuria with allopurinol treatment compared to placebo.;Timepoint(s) of evaluation of this end point: Albuminuria after the first and second treament period of 60 days each.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in arterial blood pressure and stabilisation or improved GFR during allopurinol treatment compared to placebo.;Timepoint(s) of evaluation of this end point: GFR and Blood pressure mesured after the first and second treatment period of 60 days each.