| CTRI Number |
CTRI/2026/04/108423 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE) |
|
Scientific Title of Study
|
An 18-month, open-label, single-arm safety extension study of an age-and bodyweight adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria. |
| Trial Acronym |
FIONA OLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20186 - Protocol Version 5.0 dated 21 Jun 2024 |
Protocol Number |
| 2021-002905-89 |
EudraCT |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudiksha Phadnis |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer House, Central Avenue,
Hiranandani Estate, Thane (West)
Thane
MAHARASHTRA
400607
India |
| Phone |
9619558596 |
| Fax |
|
| Email |
sudiksha.phadnis@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudiksha Phadnis |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer House, Central Avenue,
Hiranandani Estate, Thane (West)
Thane
MAHARASHTRA
400607
India |
| Phone |
9619558596 |
| Fax |
|
| Email |
sudiksha.phadnis@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudiksha Phadnis |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer House, Central Avenue,
Hiranandani Estate, Thane (West)
Thane
MAHARASHTRA
400607
India |
| Phone |
9619558596 |
| Fax |
|
| Email |
sudiksha.phadnis@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
Canada
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Italy
Lithuania
Netherlands
Poland
Portugal
Republic of Korea
South Africa
Spain
Sweden
Switzerland
Turkey
United States of America
United Kingdom
Brazil
Bulgaria
Israel
Malaysia
Mexico
Taiwan |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Hari |
All India Institute of Medical Sciences, New Delhi |
Department of Pediatrics, AIIMS Campus,
Ansari Nagar East, New Delhi – 110029,
New Delhi
DELHI |
011-26594858
pankajhari@hotmail.com |
| Dr Siddharth Mavani |
Mavani Research Center |
Second Floor, Room Number 201-202,
Kairos Building, Drive In Road,
Mayur Nagar Society, MemNagar
Ahmadabad
GUJARAT |
9825317953
msiddh@yahoo.co.in |
| Dr Pinaki Mukhopadhyay |
Nil Ratan Sircar Medical College and Hospital |
138, AJC Bose Road,
Kolkata - 700014,
Kolkata
WEST BENGAL |
91-9836471071
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 |
91-8022065003
nkamath25@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS New Delhi |
Submittted/Under Review |
| Institutional Ethics Committee, NRS Medical College |
Approved |
| Institutional Ethics Committee, St. Johns Medical College and Hospital |
Approved |
| Sangini Hospital 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 |
Finerenone (Kerendia, BAY94-8862) |
Finerenone 10 mg or 20 mg, Once daily, orally for 540 days. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be greater than or equal to 1 year to 18 years of age, at the time of signing the informed consent/assent.
2. Prior participation in the Finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
3. Participants must have a clinical diagnosis of Chronic Kidney Disease (CKD) at Visit 1.
4. 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 (BP) management, unchanged for at least 30 days prior to Visit 1.
5. K+ less than or equal to 5.0 mmol/L for children greater than or equal to 2 years of age at both FIONA EoT and Visit 1, and less than or equal to 5.3 mmol/L for children less then 2 years of age at both FIONA EoT and Visit 1.
6. Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
|
|
| ExclusionCriteria |
| Details |
1. Planned urological surgery expected to influence renal function.
2. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame.
3. Systemic hypertension Stage 2 at Visit 1.
4. Systemic hypotension at Visit 1.
5. Known hypersensitivity to the study treatment (active substance or excipients).
6. Severe hepatic insufficiency.
7. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids.
8. Concomitant therapy with a mineralocorticoid receptor antagonist (MRA) (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene).
9. Concomitant therapy with both ACEI and ARBs together.
10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers.
11. Previous assignment to treatment during this study.
12. Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
13. Experienced a drug-related serious adverse event (SAE) or an adverse event (AE) which led to permanent discontinuation of study intervention during the FIONA study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Change in serum potassium levels from baseline to Day 540 plus or minus 7 days
• Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days
• Number of participants with TEAEs |
• Change in serum potassium levels from baseline to Day 540 plus or minus 7 days
• Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days
• Number of participants with TEAEs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Urinary Protein-to-Creatinine Ratio (UPCR) and Urinary Albumin-to-Creatinine Ratio (UACR) from baseline to Day 540 plus or minus 7 days. |
From baseline to Day 540 plus or minus 7 days. |
| Change in estimated Glomerular Filtration Rate (eGFR) from baseline to Day 540 plus or minus 7 days. |
From baseline to Day 540 plus or minus 7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="20"
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)
|
20/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/11/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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
|
Finerenone has been demonstrated to be safe and efficacious in reducing proteinuria and
decreasing the risk for renal events like kidney failure, a sustained decrease in estimated
glomerular filtration rate (eGFR) of 40% or more from baseline, or renal death, as well as
cardiovascular (CV) events in a high risk population of adults with Chronic Kidney Disease
(CKD) and type 2 Diabetes (T2D). FIONA-OLE Study (20186) is part of an agreed Pediatric Investigation Plan (PIP) in the condition “treatment of CKD”. Finerenone is
currently being studied in pediatric patients with CKD and severely increased proteinuria
despite optimized treatment with an ACEI or ARB in the 6-month double-blind, placebo-controlled FIONA study (19920). The primary aim of this study is to provide data on the long-term
safety of Finerenone in the treatment of pediatric and young adult patients with CKD. In
addition, further study goals are to collect data on the long-term efficacy and to offer access to Finerenone to all participants previously treated in FIONA study (19920). |