EUCTR2004-001156-37-ES进行中（未招募）1 期
Study of Heart and Renal ProtectionEstudio de Protección Cardíaca y Renal - SHARP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,000
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
- •History of Chronic Kidney Disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l [greater than or equal to 1.7 mg/dl] in men, or greater than or equal to 130 micromol/l [greater than or equal to 1.5 mg/dl] in women); or patients on dialysis (haemodialysis or peritoneal dialysis)
- •Men or women aged greater than or equal to 40 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Definite history of myocardial infarction or coronary revascularisation procedure
- •Functioning renal transplant, or living donor-related transplant planned
- •Less than 2 months since presentation as an acute uraemic emergency (but may be entered later, if appropriate);
- •Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) or, if ALT not available, aspartate aminotransferase (AST) > 1.5 x ULN). (Note: Patients with a history of hepatitis are eligible provided these limits are not exceeded);
- •Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) >3 x ULN;
- •Definite previous adverse reaction to a statin or to ezetimibe
- •Concurrent treatment with a contraindicated drug (Note: Patients who are temporarily taking such drugs may be re-screened for participation in the study when they discontinue them, if appropriate.) These contraindicated drugs include:
- •-HMG-CoA reductase inhibitor (statin”)
- •-fibric acid derivative (fibrate”)
- •-nicotinic acid
- •-macrolide antibiotic (erythromycin, clarithromycin)
- •-systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole)
- •-protease-inhibitors (e.g. antiretroviral drugs for HIV infection)
- •-nefazodone
- •-ciclosporin
- •Child-bearing potential (i.e. premenopausal woman who is not using a reliable method of contraception.)
- •Known to be poorly compliant with clinic visits or prescribed medication
- •Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
研究者
相似试验
进行中（未招募）
不适用
Study of Heart and Renal Protection - SHARPChronic Kidney DiseaseEUCTR2004-001156-37-CZniversity of Oxford9,000
进行中（未招募）
1 期
se of levosimendan / placebo as cardio and nephroprotection in patients who are going 0n cardiac surgery with right ventricular dysfunctioEUCTR2018-004063-31-ESFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)20
已完成
不适用
The investigation of the renal protective effect of Carperitide(hANP:human atrial natriuretic peptide) during adult living donor renal transplantation, a single center experience.living donor renal transplantationJPRN-UMIN000014279Toho University School of Medicine, Department of Anesthesiology30
招募中
3 期
Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicitycardiotoxicity in patients with breast cancer receiving Anthracycline.Malignant NeoplasmsC00-C97IRCT20131218015860N7School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes60
进行中（未招募）
1 期
EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empaglifloziMedDRA version: 23.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857Chronic kidney diseaseCTIS2024-511025-63-00Boehringer Ingelheim International GmbH11,350