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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects must meet all of the following criteria:
- •1. Male or female subjects aged between 18-75 years (both inclusive).
- •2. Subject with clinically diagnosed with chronic kidney disease (CKD) (an eGFR of 30 to 60 ml/min/1.73 m2
- •3. 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:
- •1. Subjects with life expectancy less than one year
- •2. Subjects who have had renal replacement therapy in the prior 3 months
- •3. Subjects who had renal transplants or planning for renal transplantation during the study period
- •4. Evidence of recent acute kidney injury ( >50% increase in serum creatinine in the preceding 30 days)
- •5. Subjects on chronic dialysis therapy or had episode(s) of dialysis in the past 3 months
- •6. Subject having any disease/ abnormalities as follow,
- •Cardiovascular system:
- •7. 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.
- •8. Subjects with known case of Secondary or Malignant Hypertension.
- •9. Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis
- •Endocrine system:
- •10. 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:
- •11. Subjects with abnormal Liver Function Test with values more than 3 times the upper limit of normal.
- •12. Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
- •13. Subjects who is chronic smoker, alcoholic or drug abuse suspected.
- •14. Subjects with known case of HIV, Hepatitis B or C.
- •15. Subjects with medical history of oncological conditions since last 2 years.
- •16. Subjects who have participated in other clinical trials within 3 months prior to the screening examination.
- •17. Subject with hypersensitivity to any of the ingredients of the study products.
研究者
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