An Study on the Efficacy and Safety of Finerenone in Proteinuria Patients After Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
研究概览
简要总结
The goal of this clinical trial is to learn if Finerenone works to treat proteinuria patients after kidney transplantation. It will also learn about the safety of Finerenone. The main questions it aims to answer are:
Does Finerenone lower the number of UACR values in kidney transplant recipients?? What medical problems do participants have when taking Finerenone? Researchers will compare Finerenone to Dapagliflozin to see if Finerenone works to treat proteinuria patients after kidney transplantation.
详细描述
This project is designed as a single-center, prospective, randomized controlled clinical study with strict inclusion and exclusion criteria. Based on statistical sample size estimation, it aims to enroll kidney transplant recipients with proteinuria, collect basic clinical data of the recipients, and monitor primary and secondary efficacy indicators after transplantation, with the establishment of warning events. The study will further evaluate the long-term clinical benefits of Finerenone in patients with proteinuria after kidney transplantation, in order to formulate better medication plans and provide an ideal reference for similar cases (such as elevated blood creatinine after kidney transplantation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adult kidney transplant patients (≥18 years old)
- •The diagnosis and screening of chronic kidney disease (CKD) after kidney transplantation meet at least one of the following criteria:
- •Persistent high proteinuria (UACR of 30-300 mg/g, more than 2 of 3 early morning urination samples) and estimated glomerular filtration rate (eGFR) of 25-60ml/min/1.73m2 (CKD EPI) and the presence of diabetic retinopathy.
- •Persistent extremely high albuminuria (UACR≥300mg/g, more than 2 of 3 early morning urination samples) and eGFR≤25 mL /min/1.73m2 (CKD EPI)
- •Previous treatments with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor block (ARB) are as follows: A. At least 4 weeks prior to the run-in visit, subjects should receive ACEI or ARB or a combination of both
- •b. At the beginning of the run-in visit, subjects were receiving only ACEI or ARB or a combination of both.
- •c. At least 4 weeks prior to the screening visit, subjects should be treated with only the maximum tolerated labeled dose (but not less than the minimum labeled dose) of ACEI or ARB, preferably without adjustment of dose or drug selectivity or any other antihypertensive or antiglycemic therapy.
- •4. Serum potassium ≤4.8mmol/L during running-in and screening.
- •Voluntarily sign informed consent
排除标准
- •1. Kidney transplant recipients have a history of retransplantation, multiple kidney transplants, and transplantation of other organs and tissues.
- •2. Known significant non-diabetic nephropathy, including clinically relevant renal artery stenosis.
- •3. Uncontrolled arterial hypertension (i.e. mean sitting systolic blood pressure (SBP) ≥170mmHg at presentation, sitting diastolic blood pressure (DBP) ≥110mmHg, or mean sitting SBP≥160mmHg, sitting DBP≥ 100mmHg at screening)
- •In patients with type I diabetes, the hemoglobin a1C (HbA1c) is >12%.
- •Uncontrolled hypotension; The mean SBP at run-in visit or screening visit was <90mmHg
- •Chronic heart failure clinically diagnosed at run-in visit with decreased ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] Grade II-IV) (Level 1A recommendation for salocorticoid receptor antagonist MRA)
- •Hospitalization for stroke, transient ischemic attack, acute coronary syndrome, or worsening heart failure within 30 days prior to screening
- •Hemokalium was higher than 5.5mmol/L within 12 weeks after treatment due to acute renal failure
- •Patients with malignant tumors or other metabolic disorders have a history of allergic diseases or allergies
- •Severe liver damage 11 Pregnant or lactating women
- •Severe infectious diseases
- •There are other circumstances that the investigator deems inappropriate to participate in the clinical trial.
研究者
kewen Chen,MD
Attending Physician
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University