A Randomized, Double-blind, Placebo-controlled, 9-month, Parallel Group Study of Allopurinol to Reduce Left Ventricular Mass in Living Kidney Donors (AL-DON)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass
研究概览
简要总结
Recently there was described an increase in left ventricular mass after kidney donation. It is uncertain whether this is reversible or not. Allopurinol lowers uric acid in the blood and is normally indicated for gout, but studies have showed that it also can reduce the thickness of the left ventricle of the heart in people with heart- and kidney disease.
The investigators wish to give allopurinol or placebo to kidney donors based on randomization and investigate if this has the same effect on kidney donors. The investigators are assessing this by performing a cardiac MRI at baseline and after 9 months of treatment. In addition the investigators wish to see if allopurinol can have beneficial effects on blood pressure and insulin sensitivity as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney donor ≥ 6 months after donor nephrectomy
- •Donor nephrectomy undertaken in Norway
- •Male or female subject ≥ 18 years old
- •eGFR >30 ml/min/1.73 m2
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
排除标准
- •Adverse reactions to allopurinol or other xanthine oxidase inhibitors
- •Use of uric acid lowering therapy within 3 months
- •History of gout, xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy
- •History of renal calculi
- •History of coronary heart disease
- •Heart failure with left ventricular ejection fraction <45%
- •History of significant (i.e. non-physiological) cardiac valvular stenosis or insufficiency
- •History of clinically significant hepatic disease including hepatitis B or C and/or ALAT (SGPT) above the upper reference limit at screening.
- •History of HIV or AIDS
- •Severe systemic infections, current or within the last 6 months
- •History of malignancy other than localized basal cell carcinoma of the skin, treated or untreated, within the past 5 years.
- •Other life-threatening diseases
- •Haemoglobin concentration < 11 g/dL(males), <10 g/dL (females); white blood cell (WBC) count < 3.5 * 10^9/L; platelet count <50 *10^9/L at screening
- •Use of the following medications at or within 14 days before the screening visit: azathioprine, mercaptopurine, vidarabin, chlorpropamide, warfarin, tamoxifen, theophylline, amoxicillin/ampicillin, cyclophosphamide, doksorubicin, bleomycin, prokarbazin, cyclosporine, didanosine.
- •Contraindications to MRI, including: Magnetic intracranial clips. Metal fragments in orbita. Cochlea (ear) implant. Neurostimulator. Pacemaker/ICD or remaining pacemaker electrodes. Harrington rods in thorax. Claustrophobia. Unable to lie supine.
- •Pregnant or nursing (lactating) women
- •Fertile women, unless they are using effective contraception during dosing of study treatment
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究组 & 干预措施
Arm A
Allopurinol 300 mg
干预措施: Allopurinol 300 mg (Drug)
Arm B
Placebo Oral tablets
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in left ventricular mass
时间窗: Nine months
Measured change in left ventricular mass using Cardiac MRI, comparing from baseline to 9 months of treatment With allopurinol compared to placebo.
次要结局
- Change in estimated GFR(Nine months)
- Change in blood pressure(Nine months)
- Estimated insulin sensitivity, metabolic clearance rate of glucose(Nine months)
- Number of antihypertensive medications(Nine months)
- Doses of antihypertensive medications(Nine months)
- Change in urinary albumin excretion(Nine months)
研究者
Dag Olav Dahle
Principal Investigator
Oslo University Hospital