| CTRI Number |
CTRI/2023/12/060567 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| 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
|
A Retrospective Study to Evaluate the Effectiveness of NefroSave® Supplementation on Change in Microalbuminuria in Diabetes Mellitus or Hypertension: A Real-World Retrospective Study from Electronic Medical Records |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/NEF/23-001, Version-1.0 dated 24 Feb 2023 |
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 |
Medclin Research Pvt. Ltd., Acropolis, Unit 10/5, 10th Floor, 1858/1
Rajdanga Main Road, Kolkata
Kolkata
WEST BENGAL
700107
India
Kolkata
WEST BENGAL
700107
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 |
Medclin Research Pvt. Ltd., Acropolis, Unit 10/5, 10th Floor, 1858/1
Rajdanga Main Road, Kolkata
Kolkata
WEST BENGAL
700107
India
WEST BENGAL
700107
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 |
Medclin Research Pvt. Ltd., Acropolis, Unit 10/5, 10th Floor, 1858/1
Rajdanga Main Road, Kolkata
Kolkata
WEST BENGAL
700107
India
WEST BENGAL
700107
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 |
Medclin Research Pvt Ltd |
Medclin Research Pvt.
Ltd., Acropolis, Unit
10/5, 10th Floor, 1858/1
Rajdanga Main Road,
Kolkata WEST
BENGAL 700107 India
Kolkata
WEST BENGAL |
9831075734
monjori.mitra@medclinsearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
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.Adult patients with diabetes mellitus or hypertension maybe diagnosed with chronic kidney disease (CKD) Stage 1, Stage 2 and up to Stage 3.
2. Adult patients with microalbuminuria result ranging from 30-300mg/day. |
|
| ExclusionCriteria |
| Details |
Patients with 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 |
| Change in urinary albumin to creatinine ratio (uACR) from baseline to study end |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in microalbuminuria within treatment time period of 3 months
2.Tolerability evaluated based on adverse events recorded by the treating physician during the treatment period of 3 months
3.Casualty assessment of adverse events recorded by the treating physician, if any |
3 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
26/12/2023 |
| 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="6"
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 study is based on data gathered in the electronic medical records for patients of diabetic and hypertensive patients diagnosed with stage 1, stage 2, or stage 3 chronic kidney disease (CKD) and prescribed to receive NefroSave® supplementation. The information will be extrapolated from the electronic medical record database in an anonymized aggregate manner so as to mask patient identifiers. Each patient gets a unique patient identifier or a unique patient ID once they are registered on the database and patient |