| CTRI Number |
CTRI/2025/08/093387 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Electronic Medical Record Study |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of supplementation of Nefrosave® in Chronic Kidney Disease |
|
Scientific Title of Study
|
Effectiveness and tolerability of N-acetylcysteine and taurine in patients of chronic kidney disease with type 2 diabetes mellitus and/or hypertension: A real-world, retrospective, comparative study from electronic medical records |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/NFS/25-008 Version 1.0 Dated 26 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monjori Mitra |
| Designation |
Research Director |
| Affiliation |
Medclin Research Pvt Ltd |
| Address |
BO: 509, Metro Avenue Pereira Road, Off Andheri-Kurla Road, Near WE Highway Metro Station, Andheri (East), Mumbai 400099
Mumbai
MAHARASHTRA
400099
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjori.mitra@medclinsearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monjori Mitra |
| Designation |
Research Director |
| Affiliation |
Medclin Research Pvt Ltd |
| Address |
BO: 509, Metro Avenue Pereira Road, Off Andheri-Kurla Road, Near WE Highway Metro Station, Andheri (East), Mumbai 400099
Mumbai
MAHARASHTRA
400099
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjori.mitra@medclinsearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monjori Mitra |
| Designation |
Research Director |
| Affiliation |
Medclin Research Pvt Ltd |
| Address |
BO: 509, Metro Avenue Pereira Road, Off Andheri-Kurla Road, Near WE Highway Metro Station, Andheri (East), Mumbai 400099
Mumbai
MAHARASHTRA
400099
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjori.mitra@medclinsearch.com |
|
|
Source of Monetary or Material Support
|
| Fourrts India Laboratories Pvt Ltd Plot No-1.Fourrts Avenue, Annai Indira Nagar, Okkiyam,Thoraipakkam, Chennai-600097 |
|
|
Primary Sponsor
|
| Name |
Fourrts India Laboratories Pvt Ltd |
| Address |
Plot No-1.Fourrts Avenue, Annai Indira Nagar, Okkiyam, Thoraipakkam,Chennai-600097 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monjori Mitra |
MedclinResearchPvt Ltd |
BO: Room number 509,5th Floor, Department of Clinical Research, Medclin Research Pvt. Ltd. Re Metro Avenue Pereira Road, Off Andheri-Kurla Road, Near WE Highway Metro Station, Andheri (East), Mumbai 400099
Mumbai
MAHARASHTRA |
9831075734
monjori.mitra@medclinsearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients more than and equal to 18 years of age
2. Diagnosis of stage 1, stage 2, or stage 3 chronic kidney disease (CKD) as per the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI)
3. Diagnosis of type 2 diabetes mellitus (T2DM) and/or hypertension (HTN) by the treating cardiologist
4. Patients on standard of care with or without N-acetylcysteine (NAC; 150 mg) and taurine (500 mg), as prescribed by the treating cardiologist
5. Patients with available data on uACR, serum creatinine, and eGFR as part of routine clinical practice at least at baseline and after 12+2 weeks of treatment |
|
| ExclusionCriteria |
| Details |
1. Incomplete medical records with respect to the required study parameters |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in urinary albumin to creatinine ratio (uACR) from baseline to 12±2 weeks of treatment
2. Change in serum creatinine levels from baseline to 12±2 weeks of treatment |
1. Baseline to 12±2 weeks of treatment
2. Baseline to 12±2 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in eGFR from baseline to 12+2 weeks of treatment |
Baseline, 12±2 weeks |
| Proportion of patients with adverse events (AEs) and serious AEs (SAEs) |
Baseline to 12±2 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This real-world, retrospective, multicentric, comparative study will assess the effectiveness and tolerability of NAC (150 mg) and taurine (500 mg) on the management of microalbuminuria, creatinine levels, and eGFR in patients of CKD with T2DM and/or HTN (as diagnosed by the treating cardiologist) in India using data retrieved from electronic medical records (EMRs). Aggregated and anonymized data will be retrieved for a period of at least 12+2 weeks after treatment initiation from approximately 450 EMRs (300 treated with NAC + taurine + standard of care; 150 treated with standard of care) of patients satisfying the study eligibility criteria. Patient confidentiality will be maintained at all times, as the study will be performed using anonymized patient information only. |