| CTRI Number |
CTRI/2021/04/032987 [Registered on: 21/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Prospective Trial of Renochlor Formulation as an add on to the Standard of care for the Management of Chronic Renal Failure (CRF) |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniruddha Gokhale |
| Designation |
Principal Investigator |
| Affiliation |
Dr.Gokhales Urology & Gynaecology Clinic |
| Address |
Next Cafe Coffee Day, Dr.Gokhales Urology & Gynaecology Clinic, GREENWOODS CHD,Link road, off, Shimpoli Rd, Borivali West, Mumbai, Maharashtra 400092
Next Cafe Coffee Day, Dr.Gokhales Urology & Gynaecology Clinic, GREENWOODS CHD,Link road, off, Shimpoli Rd, Borivali West, Mumbai, Maharashtra 400092
Thane
MAHARASHTRA
400092
India |
| Phone |
9820271476 |
| Fax |
|
| Email |
draniruddhagokhale10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
4thFloor, Ambika Idustries, Opp. Thakur Mall, Penkarpada Rd, Mira Road, Maharashtra 401107
4thFloor, Ambika Idustries, Opp. Thakur Mall, Penkarpada Rd, Mira Road, Maharashtra 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Gharpure |
| Designation |
Senior General Manager |
| Affiliation |
THINQ Pharma CRO Limited |
| Address |
A30, Rd Number 10, Wagle Estate, MIDC, Thane West, Thane, Maharashtra 400604
A30, Rd Number 10, Wagle Estate, MIDC, Thane West, Thane, Maharashtra 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
9820726954 |
| Fax |
|
| Email |
milind@thinqcro.com |
|
|
Source of Monetary or Material Support
|
| THINQ Pharma CRO Limited, A30, Rd Number 10, Wagle Estate, MIDC, Thane West, Thane, Maharashtra 400604 |
|
|
Primary Sponsor
|
| Name |
Thinq Pharma CRO Limited |
| Address |
A30, Rd Number 10, Wagle Estate, MIDC, Thane West, Thane, Maharashtra 400604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aniruddha Gokhale |
Dr.Gokhales Urology & Gynaecology Clinic |
Next Cafe Coffee Day, Dr.Gokhales Urology & Gynaecology Clinic, GREENWOODS CHD,Link road, off, Shimpoli Rd, Borivali West, Mumbai, Maharashtra 400092
Thane
MAHARASHTRA |
9820271476
draniruddhagokhale10@gmail.com |
| Dr Anurag Shukla |
Mother Teresa Multispeciality Hospital |
Satpala Naka, Pipri Dontalav, Virar West, Vasai-Virar, Maharashtra 401301
Thane
MAHARASHTRA |
9764718377
dranuragshuklamth@gmail.com |
| Dr B R Ramesh Rao |
Sanjeevani Kidney Care |
20, Plot No-51/52, Next to Sanjeevani Hospital, Nityapriya Society, Nityanandan, Andheri East, Mumbai, Maharashtra 400069
Thane
MAHARASHTRA |
9820075652
drrameshrao10@gmail.com |
| Dr Chaitanya Sawant |
Vijay Vallabh Hospital |
Tirupati Nagar Rd, beside Banjara Hotel, Phase 1, Tirupati Nagar, Virar West, Virar, Maharashtra 401303
Thane
MAHARASHTRA |
9082805199
drchaitanyasawantvvh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Renochlor Syrup (Each 10 ml contains 40 mg of Sodium Copper Chlorophyllin) |
10 ml three times a day, Each 10 ml contains 40 mg of Sodium Copper Chlorophyllin (Oral route, for 90 days) |
| Intervention |
Renochlor Tablet 40 mg active Sodium Copper Chlorophyllin |
1 tablet of 40 mg active Sodium Copper Chlorophyllin, 3 times in a day (Oral route, for 90 days) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline of eGFR |
Day -3, Day 30, 60 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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). |