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.

Phase 3

Not yet recruiting

• Conditions: Chronic kidney disease, unspecified,

• Registration Number: CTRI/2025/04/084877
• Lead Sponsor: Bayer Pharmaceuticals Private Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-30
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (3)

All India Institute of Medical Sciences New Delhi; 🇮🇳 Central, DELHI, India

Nil Ratan Sircar Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

St. Johns National Academy of Health Sciences; 🇮🇳 Bangalore, KARNATAKA, India

All India Institute of Medical Sciences New Delhi

🇮🇳Central, DELHI, India

Dr Pankaj Hari

Principal investigator

911126594858

pankajhari@hotmail.com