EUCTR2014-001786-26-DK进行中（未招募）1 期
A randomised, doublet blinded, placebo controlled cross-over study of Allopurinols effect to prevent loss of kidney function in type 1 diabetes - MIKA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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