Type 1 diabetes and microalbuminuria. MedDRA version: 18.0 Level: LLT Classification code 10037827 Term: Raised serum uric acid System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Allopurinol "DAK"
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ALLOPURINOL
Other descriptive name: Hexanurat
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Steno Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Contacts
Public ContactDiabetes complications research
Steno Diabetes Center
Outcome results
None listed