A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improved Albuminuria
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Albuminuria (≥30 mg/g)
- •Uric Acid ≥ 0,265 mmol/l
- •GFR (glomerular filtration rate) > 40 ml/min/1.73m2
排除标准
- •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.
研究组 & 干预措施
Allopurinol
400 mg once daily, tablet treatment
干预措施: Allopurinol (Drug)
Placebo
Identical tablet treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Improved Albuminuria
时间窗: 60 days
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.
次要结局
未报告次要终点
研究者
Peter Rossing
Senior Principal Investigator, Professor, Chief Physician, DMSc
Steno Diabetes Center Copenhagen