| CTRI Number |
CTRI/2025/04/084877 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| 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 Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor in Children With Chronic Kidney Disease and Proteinuria. |
|
Scientific Title of Study
|
A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to 18 years of age, with chronic kidney disease and proteinuria |
| Trial Acronym |
FIONA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2021-002071-19 |
EudraCT |
| Protocol Version 06 Dated 17 Jun 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand Pendse |
| Designation |
Manager Clinical Operations |
| Affiliation |
Manager Clinical Operations |
| Address |
Bayer Pharmaceuticals Private Limited
Bayer House
Central Avenue
Hiranandani Estate
Thane
MAHARASHTRA
400607
India |
| Phone |
919820563905 |
| Fax |
|
| Email |
anand.pendse@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Pendse |
| Designation |
Manager Clinical Operations |
| Affiliation |
Manager Clinical Operations |
| Address |
Bayer Pharmaceuticals Private Limited
Bayer House
Central Avenue
Hiranandani Estate
MAHARASHTRA
400607
India |
| Phone |
919820563905 |
| Fax |
|
| Email |
anand.pendse@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Anand Pendse |
| Designation |
Manager Clinical Operations |
| Affiliation |
Manager Clinical Operations |
| Address |
Bayer Pharmaceuticals Private Limited
Bayer House
Central Avenue
Hiranandani Estate
MAHARASHTRA
400607
India |
| Phone |
919820563905 |
| Fax |
|
| Email |
anand.pendse@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Pharmaceuticals Private Limited
Bayer House
Central Avenue
Hiranandani Estate
Thane 400607
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer House
Central Avenue
Hiranandani Estate
Thane 400607
Maharashtra
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Lithuania
Malaysia
Mexico
Netherlands
Poland
Portugal
Republic of Korea
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Hari |
All India Institute of Medical Sciences New Delhi |
Dr. Pankaj Hari
All India Institute of Medical Sciences New Delhi
Pediatric Department
Mother and Child Hospital
8 Floor Room number 823
Ansari Nagar
New Delhi
Central
DELHI |
911126594858
pankajhari@hotmail.com |
| Dr Pinaki Mukhopadhyay |
Nil Ratan Sircar Medical College and Hospital |
Department of Pediatric
Third Floor
138 A J C Bose Road
Sealdah
Raja bazaar
Kolkata 700014
Kolkata
WEST BENGAL |
919836471071
drpinaki71@yahoo.com |
| Dr Nivedita Kamath |
St. Johns National Academy of Health Sciences |
Department of Pediatrics
Unit of Hope Building
Second Floor
Sarjapur Road
Bangalore 560034
Bangalore
KARNATAKA |
918022065003
nkamath25@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS New Delhi |
Approved |
| Institutional Ethics Committee N R S Medical College |
Approved |
| Institutional Ethics Committee St Johns Medical College and Hospital |
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 |
| Comparator Agent |
Drug: Placebo |
Placebo to finerenone,
10 mg or 20 mg,
Once daily, orally for 180 days. |
| Intervention |
Finerenone (Kerendia, BAY94-8862) |
Finerenone 10 mg or 20 mg,
Once daily, orally for 180 days. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants must be 6 months to less than 18 years old at the time when the informed consent/assent is signed.
Participants must have a clinical diagnosis of chronic kidney disease CKD at screening
Participants must have stable kidney function
Treated with an angiotensin-converting enzyme inhibitor ACEI or angiotensin receptor blocker ARB at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days |
Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number participants with treatment emergent adverse events |
From the start of study intervention (Baseline) to last study intervention plus THREE days up to 190 days |
| Change in serum potassium levels from baseline to day 180 Plus or Minus Seven days |
From baseline to day 180 Plus or Minus Seven days |
| Change in eGFR from baseline to day 180 Plus or Minus 7 days |
From baseline to day 180 Plus or Minus 7 days |
|
|
Target Sample Size
|
Total Sample Size="219"
Sample Size from India="10"
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)
|
30/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/01/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.
The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.
The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants’ urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. |