| CTRI Number |
CTRI/2021/11/037917 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A trial to learn how well finerenone works & how safe it is in adult participants with nondiabetic
chronic kidney disease |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to
investigate the efficacy and safety of FInerenone, in addition to standard of care, on the
progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease |
| Trial Acronym |
FIND-CKD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2021-000421-27 |
EudraCT |
| 21177 Version 2.0 dated 05 Jul 2021 |
Protocol Number |
| CT/21/000088 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Mumbai (Suburban)
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central Avenue,
Thane
Mumbai (Suburban)
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer AG, 51368 Leverkusen, Germany |
|
|
Primary Sponsor
|
| Name |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited,
Pharmaceuticals Division,
Research and Development Pharmaceuticals,
Bayer House,
Central Avenue,
Thane - 400607
Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Bulgaria
China
Czech Republic
Denmark
Greece
Hong Kong
India
Israel
Italy
Japan
Malaysia
Mexico
Russian Federation
Spain
Taiwan
United States of America
Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arunkumar Subbiah |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences,
Department of Nephrology,
5th Floor, Ansari Nagar, New Delhi - 110029
North
DELHI |
9968969076
gmedaks@gmail.com |
| Dr Noble Gracious |
Government Medical College Trivandrum |
Research Room Ground Floor
Department of Nephrology
Super Speciality Block
Ulloor
Thiruvananthapuram
KERALA |
9446390313
noblegracious@hotmail.com |
| Dr Rajendra Pandey |
Institute of Post Graduate Medical Education & Research |
IPGMER, Department of Nephrology,
244 AJC Bose Road, Kolkata-700020, West Bengal, India
Kolkata
WEST BENGAL |
9433033163
rajensankrityan@gmail.com |
| Dr Sakthirajan Ramanathan |
Madras Medical College Chennai |
Institute of Nephrology
5th floor
E V R Periyar Salai
Park Town
Chennai
TAMIL NADU |
9444126080
draatral@gmail.com |
| Dr Siddharth Mavani |
Mavani Dialysis and Kidney Center. |
Second Floor, Mavani Research Center, Kairos Complex, Near Manav Mandir, Drive-In Road. 380052 Gujarat
Ahmadabad
GUJARAT |
9825317953
msiddh@yahoo.co.in |
| Dr Dinesh Khullar |
Max Super Speciality Hospital |
Max Super Speciality Hospital, 1-Press Enclave Road , West Block, Ground Floor, Nephrology OPD, Saket, New-Delhi-110017
South
DELHI |
01126692266
Dinesh.Khullar@maxhealthcare.com |
| Dr Avinash Ignatius |
Noble Hospital Pvt. Ltd |
Noble Hospital Pvt. Ltd.,
Noble Hospital Clinical Research Department, Noble Annex, 153 A, Magarpatta City, Road, Pune-411013, Maharashtra, India
Pune
MAHARASHTRA |
9823101982
dr_ignatius@yahoo.co.in |
| Dr Manisha Sahay |
Osmania General Hospital |
Department of Nephrology,
3rd Floor of QQDC Building, Osmania General Hospital, Afzalgunj, Hyderabad-500012, Telangana.
Hyderabad
TELANGANA |
9849097507
drmanishasahay@gmail.com |
| Dr Alan Almeida |
P. D Hinduja Hospital & Medical Research Centre |
P.D Hinduja Hospital & MRC, SVS Road, Mahim West, Shivaji Park, Mumbai-400016
Mumbai (Suburban)
MAHARASHTRA |
9322879750
almeidaa@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee Shalby Limited |
Approved |
| Human Ethics Committee Government Medical College, Thiruvananthapuram |
Approved |
| Institute Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee Madras Medical College Chennai |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Institutional Ethics Committee, P.D Hinduja Hospital & MRC |
Approved |
| IPGME&R Research Oversight Committee |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
| Sangini Hospital 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 |
| Intervention |
Finerenone (BAY94-8862)
|
10 mg or 20 mg tablets once daily orally for 32 months. |
| Comparator Agent |
Placebo |
10 mg or 20 mg placebo tablets once daily orally for 32 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
A clinical diagnosis of chronic kidney disease and
Urine albumin to creatinine ratio of more than equal to 200 but less than equal to 3500 mg/g and estimated glomerular filtration rate more than equal to 25 but less than 90 mL/min/1.73 at screening and
Documentation of albuminuria/proteinuria in the participant’s medical records at least 3 months prior to screening.
Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor or Angiotensin receptor blocker for at least 4 weeks prior to screening
Potassium less than equal to 4.8 mmol/L at screening |
|
| ExclusionCriteria |
| Details |
Established diagnosis of Type 1 or 2 Diabetes mellitus or HbA1c more than equal to 6.5 percent.
Autosomal dominant or autosomal recessive polycystic kidney disease
Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean rate of change as measured by the total
slope of eGFR from baseline to Month-32 |
From baseline to month 32 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to the composite of kidney failure, sustained
eGFR decline of more than equal to 57 percent, heart failure
hospitalization or Cardiovascular death |
Up to end of study visit -up to approximately 49
months |
Time to the composite of kidney failure or
sustained eGFR decline of more than equal to 57 percent. |
Up to end of study visit -up to approximately 49
months |
Time to the composite to heart failure
hospitalization or CV death |
Up to end of study visit - up to approximately 49
months |
Number of participants with Treatment-emergent
adverse events
Treatment-emergent serious adverse events and Adverse
events of special interest |
Up to approximately 50 months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="50"
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)
|
10/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants’ non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months.
During the trial, the doctors will collect blood and urine samples and check the participants’ health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments. |