EUCTR2017-004641-25-IT进行中（未招募）1 期
Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-3) - ROTATE-3
IVERSITY MEDICAL CENTER GRONINGE0 个研究点目标入组 46 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- •eGFR > 30 and < 90 ml/min/1.73m2
- •Albuminuria = 100 mg/24 hour and = 3500 mg/24 hour
- •Serum potassium = 5.0 mmol/L
- •Treatment with ACEi or ARB
- •Age = 18 years
- •Written informed consent
- •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 26
排除标准
- •Diagnosis of type 1 diabetes mellitus
- •Urinary protein excretion > 3500 mg/24 hour
- •Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
- •Indication for immunosuppressants as per the treating physician’s judgment.
- •Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
- •Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- •Diabetes type 2 patients with recent (last 6 months) of hyperosmolar hyperglicemic state who are prone to development redistributive hyperkalemia (movement of potassium out of the cells)
- •Pregnant women and women of child-bearing potential who are not using reliable contraception
- •Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
- •Uncontrolled blood pressure (office blood pressure > 160 / 100 mmHg)
- •History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
- •History of amputations
- •eGFR change > 30% in the last six months before study randomization
- •Current therapy with renin inhibitor or MRA
- •Concomitant treatment with ACEi and ARB
- •Intolerance or contraindications to drugs inhibiting the Renin-Angiotensin-Aldosterone System (RAAS). Cyclosporine A, tacrolimus, trimethoprim due to increased risk of hyperkalemia in combination with eplerenone. Ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazadone, lithium, amiodarone, diltiazem, verapamil due to increase in toxicity when combined with eplerenone. Rifampicin, carbamazepine, phenytoin, phenobarbital due the risk of decreased eplerenone efficacy.
- •Participation in any clinical investigation within 3 months prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
- •History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- •Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications
研究者
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