A Prospective Trial of Renochlor Formulation as an add on to the Standard of care for the Management of Chronic Renal Failure (CRF)

Phase 3

Not yet recruiting

• Conditions: Chronic kidney disease, stage 3 (moderate),

• Registration Number: CTRI/2021/04/032987
• Lead Sponsor: Thinq Pharma CRO Limited

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-26
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Subjects must meet all of the following criteria: 1.
• 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 3.
• Subject voluntarily provides written informed consent and comes for regular follow up.

Exclusion Criteria

• 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.
• Subjects with known case of Secondary or Malignant Hypertension.
• 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of eGFR	Day -3, Day 30, 60 and 90

Secondary Outcome Measures

Name	Time	Method
Change in Albumin-to-creatinine ratio (ACR)	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 Serum Creatinine	Day -3, Day 30, 60 and 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

Trial Locations

Locations (4)

Dr.Gokhales Urology & Gynaecology Clinic; 🇮🇳 Thane, MAHARASHTRA, India

Mother Teresa Multispeciality Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Sanjeevani Kidney Care; 🇮🇳 Thane, MAHARASHTRA, India

Vijay Vallabh Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Dr.Gokhales Urology & Gynaecology Clinic

🇮🇳Thane, MAHARASHTRA, India

Dr Aniruddha Gokhale

Principal investigator

9820271476

draniruddhagokhale10@gmail.com