EUCTR2017-004641-25-ES进行中（未招募）1 期
Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation. - ROTATE 3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
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 including, but not limited to any of the following:major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
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