| CTRI Number |
CTRI/2025/07/090948 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Real-world data on Finerenone
treatment in patients with chronic kidney disease
and type 2 diabetes. |
|
Scientific Title of Study
|
Real-world experience with Finerenone treatment in patients from India with chronic kidney disease
and type 2 diabetes Retrospective data analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Manjrekar |
| Designation |
Therapeutic Area Head, Medical–CKM, Diabetes |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited
New Bayer House, Central Avenue
Hiranandani Estate Thane (W)- 400607 India
Thane
MAHARASHTRA
400607
India |
| Phone |
9890894139 |
| Fax |
|
| Email |
pravin.manjrekar@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Manjrekar |
| Designation |
Therapeutic Area Head, Medical–CKM, Diabetes |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited
New Bayer House, Central Avenue
Hiranandani Estate Thane (W)- 400607 India
Thane
MAHARASHTRA
400607
India |
| Phone |
9890894139 |
| Fax |
|
| Email |
pravin.manjrekar@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Manjrekar |
| Designation |
Therapeutic Area Head, Medical–CKM, Diabetes |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited
New Bayer House, Central Avenue
Hiranandani Estate Thane (W)- 400607 India
Thane
MAHARASHTRA
400607
India |
| Phone |
9890894139 |
| Fax |
|
| Email |
pravin.manjrekar@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Zydus Pharma Private Limited (BZPPL) India, Bayer House, Central Avenue
400607 Thane
India
|
|
|
Primary Sponsor
|
| Name |
Bayer Zydus Pharma Private Limited (BZPPL) India |
| Address |
Bayer Zydus Pharma Private Limited
New Bayer House Central Avenue,
Hiranandani Estate Thane (W)- 400607 India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debmalya Sanyal |
ANANDA CLINIC |
568, Diamond Harbour Rd, Auddy Bagan Basti, Behala, Kolkata, West Bengal 700034
Kolkata
WEST BENGAL |
9830118388
drdebmalyasanyal@gmail.com |
| Dr Vijoy Kumar Jha |
BASE HOSPITAL DELHI CANT (BHDC) |
Department of Nephrology, Medical division, BHDC - 10, Channan Singh Park, Delhi Cantonment, New Delhi - 110010
New Delhi
DELHI |
9818180755
vkjhamd@gmail.com |
| Dr Ratan Jha |
Care Hospital |
Outpatient Centre, Babukhan Chambers, Road No. 10,Avenue 4, Banjara hills, Hyderabad, Telangana- 500034
Hyderabad
TELANGANA |
9848027683
jharatan08@gmail.com |
| Dr Pulin Gupta |
Dr. Ram Manohar Lohia Hospital |
RML Hospital, Baba Kharak Singh Marg,Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI |
9899748321
guptapulin@yahoo.com |
| Dr Sanjeev Gulati |
Fortis Escort Heart Insitute |
Masihgarh, Okhla Road, New Delhi, Delhi 110025
New Delhi
DELHI |
9871600885
sgulati2002@gmail.com |
| Dr Upal Sengupta |
Fortis Hospital & Kidney Institute |
111A, Rashbehari Ave, Dover Terrace, Ballygunge, Kolkata, West Bengal-700029
Kolkata
WEST BENGAL |
9830922466
clinicalresearch@fortishealthcare.com |
| Dr Parag Shah |
Gujarat Endocrine Centre |
AWS 3, 518-526, Drive-In Road, Opp. Manav Mandir Road, Near Helmet Circle, Sushil Nagar Society, Memnagar, Ahmedabad, Gujarat- 3800009
Ahmadabad
GUJARAT |
9824042688
paragendo@gmail.com |
| Dr Shivendra Singh |
Institute of Medical Sciences Institute of Medical Sciences Banaras Hindu University |
Aurobindo Colony, Bhelupur, Varanasi, Uttar Pradesh - 221005
Varanasi
UTTAR PRADESH |
9415224504
ssshivendrabhu@gmail.com |
| Dr Praveen Murlidharan |
KIMS Health hospital |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA |
9746215474
praveen.murlidharan@gmail.com |
| Dr R K Sharma |
Medanta Superspeciality Hospital |
Sector A Pocket 1 Amar Shaheed Path Golf City Lucknow Uttar Pradesh 226030
Lucknow
UTTAR PRADESH |
9415026762
drrksharma53@yahoo.com |
| Dr Vijay Viswanathan |
Prof. M Viswanathan Diabetes Research Centre |
4 West Madha Church Street, Royapuram, Chennai 600 013
Chennai
TAMIL NADU |
9841598463
clinicalresearch@mvdiabetes.in |
| Dr Sooraj YS |
Renai Medicity |
Palarivattom Edapally Road, Near Palarivattom Metro Station Palarivattom P.O, Kochi, Kerala 682025
Ernakulam
KERALA |
9633177608
drsooraj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| CARE Hospitals, Institutional Ethics Committee 6-3-248/2, Care Hospital, In-Patient building, 4th Floor Room No. 401, Road No-1, Banjara Hills Hyderabad Telangana 500034India |
Submittted/Under Review |
| Ethics Committee, PGIMER, Dr. RML Hospital PGIMER, DR. RAM MANOHAR LOHIA HOSPITAL, NEW DELHI Baba Khadakh Singh Marg New Delhi New Delhi Central Delhi Delhi - 110001 |
Submittted/Under Review |
| Fortis Hospital Ethics Committee , 730, Anandapur EM Bypass Road, Kolkata, West Bengal - 700107 |
Submittted/Under Review |
| Indira IVF Hospital Ethics Committee - Kolkata Indira IVF Hospital Pvt. Ltd. 57B, Park Street Mirza Galib Street Kolkata Kolkata West Bengal - 700016 India |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE FORTIS ESCORTS HEART INSTITUTE Room No A - 22, 23,2nd Floor RC Building Okhla Road New Delhi New Delhi Delhi - 110025 India |
Submittted/Under Review |
| Institutional Ethics Committee Institute of Medical Sciences Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi Uttar Pradesh - 221005 India |
Submittted/Under Review |
| Institutional Ethics Committee Medanta Lucknow Medanta Hospital Lucknow Sector A, Pocket 1 Sushant Golf City, Shaheed Path Lucknow Lucknow Uttar Pradesh - 226030 India |
Submittted/Under Review |
| Institutional Ethics Committee Polakulath Narayanan Renai Medicity Post Box No. 2259 Palarivattom P.O. Ernakulam Ernakulam Ernakulam Kerala - 682025 India |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE YASHODAACADEMY OF MEDICAL EDUCATION AND RESEARCH |
Submittted/Under Review |
| Institutional Ethics Committee, Base Hospital Delhi Cantt, Chanan Singh Park, Delhi Cantonment, New Delhi - 110010 |
Submittted/Under Review |
| Institutional Human Ethics Committee KIMSHEALTH PB.No.1 Anayara Trivandrum Thiruvananthapuram Kerala - 695029 India |
Approved |
| KIRAN HOSPITAL AND ETHICS COMMITTEE |
Approved |
| Prof. M.Viswanathan Diabetes Research Centre |
Approved |
| Sangini Hospital Ethics Committee Sangini Hospital Santorini Square, B/H Abhishree Complex Opp. Star Bazar Nr Jodhpur Cross Roads Satellite Ahmedabad Ahmedabad Gujarat - 380015 India |
Submittted/Under Review |
|
|
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 |
Finerenone |
Finerenone 10/20mg OD, Route of administration is Oral. Duration of treatment is 6 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating
finerenone (per the standard diagnostic criteria) and initiated on finerenone per
approved label.
Patient was prescribed finerenone for the first time (drug naive) for the management of
CKD and T2D between 1st August 2022 and 30th April 2024.Age 18 years or older at the time of finerenone initiation. |
|
| ExclusionCriteria |
| Details |
Patients with the following recorded data (on or within 90 days before finerenone initiation)
will be excluded:
eGFR less than 25 mL per min per 1.73 metre square
Serum potassium more than 5.0 mmol per Litre
Type 1 diabetes is recorded in the patient record
Contraindications according to the local marketing authorization Patient data will be
excluded if below information is identified in the patient record at any point from index
date to the end of observation period:
Pregnancy.
Lactation.
Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g.,
itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin,
telithromycin and nefazodone). Addisons disease.
Patient was a part of an interventional clinical study between 1st August 2022 and 30th
Nov 2024. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Describe demographic and clinical characteristics comorbidities comedications and finerenone drug utilization patterns in patients with chronic kidney disease and Type 2 Diabetes treated with finerenone in routine clinical practice in India. |
Patient information will be captured and entered the eCRF covering the baseline period, from 6 months prior to index until finerenone initiation (index), and during follow-up from 1 day after index until 30 November 2024 (or patient censorship) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Assess absolute and relative changes in serum
potassium and key measures of kidney function
-urine albumin-to-creatinine ratio UACR and
eGFR over time after initiation of finerenone.
• Describe the occurrence of hyperkalemia hospitalization and dialysis due to hyperkalemia after initiating finerenone. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes mellitus is one of the most common causes of chronic kidney disease (CKD) and associated kidney failure. It has been estimated that globally about 20% and 40% of individuals with diabetes are diagnosed with diabetic nephropathy. More than 40% of patients with type 2 diabetes (T2D) had CKD in India. Patients with T2D and CKD are at a high risk of mortality. Based on the benefits noted in preclinical and clinical trials, the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) recommend the usage of nonsteroidal mineralocorticoid receptor antagonist (nsMRA) for patients with T2D, normal serum potassium levels, estimated glomerular filtration rate (eGFR) 25 mL/min/1.73 m2 , and albumin-to creatinine ratio (ACR) 30 mg/g. Finerenone is a nsMRA that has been approved for the management of CKD among patients with T2D. The nsMRA has shown lower risk of hyperkalemia compared with traditional mineralocorticoid receptor antagonists (MRAs) like spironolactone. The benefits of finerenone in the primary and secondary prevention of cardiovascular (CV) events among patients with CKD and T2D have been established in various trials. As all safety and efficacy information currently available stems from controlled clinical trials that did not include Indian patients, we lack real-world data and experiences from routine clinical practice in India. Therefore, it is crucial to gather and evaluate data on the usage of finerenone shortly after its marketing approval, in patients prescribed this medication as part of their routine clinical care in India. Furthermore, it is essential to delineate patient characteristics and the patterns of drug utilization among these individuals to support the potential application of finerenone in clinical practice. The planned observational study is designed to obtain insights about the real-world treatment practice with finerenone in the clinical management of patients with CKD and T2D, across different patient care settings in India. |