CTRI/2021/04/032987尚未招募3 期
A Prospective, Observational, Randomized, Open labeled, Multi Center, Parallel-Group, Two arm, Clinical trial Study to Evaluate the Efficacy, Safety and Tolerability of Renochlor Formulation as an add on to the Standard of care for the Management of Chronic Renal Failure (CRF)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Change from baseline of eGFR
研究概览
简要总结
A Prospective, Observational, Randomized, Open labelled, Multi Center, Parallel-Group, Two arm, Clinical trial Study to Evaluate the Efficacy, Safety and Tolerability of Renochlor Formulation as an add on to the Standard of care for the Management of Chronic Renal Failure (CRF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria:
- •Male or female subjects aged between 18-75 years (both inclusive).
- •Subject with clinically diagnosed with chronic kidney disease (CKD) (an eGFR of 30 to 60 ml/min/1.73 m2
- •Subject voluntarily provides written informed consent and comes for regular follow up.
排除标准
- •Subjects will be excluded if ANY of the following conditions apply:
- •Subjects with life expectancy less than one year
- •Subjects who have had renal replacement therapy in the prior 3 months
- •Subjects who had renal transplants or planning for renal transplantation during the study period
- •Evidence of recent acute kidney injury (>50% increase in serum creatinine in the preceding 30 days)
- •Subjects on chronic dialysis therapy or had episode(s) of dialysis in the past 3 months
- •Subject having any disease/ abnormalities as follow, Cardiovascular system:
- •Subject with unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery and any clinically significant cardiac arrhythmias.
- •Subjects with known case of Secondary or Malignant Hypertension.
- •Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis Endocrine system:
- •Subjects with uncontrolled Type 1 and Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •Hepatic system:
- •Subjects who is chronic smoker, alcoholic or drug abuse suspected.
- •Subjects with known case of HIV, Hepatitis B or C.
- •Subjects who have participated in other clinical trials within 3 months prior to the screening examination.
- •Subject with hypersensitivity to any of the ingredients of the study products.
结局指标
主要结局
Change from baseline of eGFR
时间窗: Day -3, Day 30, 60 and 90
次要结局
- Change in Albumin-to-creatinine ratio (ACR)(Day -3, Day 30, 60 and 90)
- Change in Serum Creatinine(Day -3, Day 30, 60 and 90)
- Change in TGF-β1 from baseline visit to end of study visit(Day -3 and day 90)
- Change in BUN and electrolytes as compared to baseline.(Day -3, Day 30, 60 and 90)
- Incidence rates of AE/ SAE including changes in vital signs and laboratory parameters(Day -3, Day 1, Day 30, 60 and 90)
- Kidney Disease Quality of Life (KDQOL-SFTM) Version 1.3(Day -3 and Day 90)
研究者
研究点 (4)
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