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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer AG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

7 Nov 2022 → ongoing

Decision date (initial)

2024-05-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bayer AG

External identifiers

EU CT number

2023-504885-50-00

EudraCT number

2021-002905-89

ClinicalTrials.gov

NCT05457283

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacokinetic, Therapy

To demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.

Secondary objectives 1

1. To assess the long-term treatment effects on proteinuria and kidney function of finerenone in addition to standard of care

Conditions and MedDRA coding

Treatment of children with chronic kidney disease and proteinuria

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001623-PIP01-14

Plan to share IPD

No

IPD plan description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Participants must be ≥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 which is defined as - CKD stages 1-3 (estimated glomerular filtration rate [eGFR] ≥30 mL/min/1.73m^2) for children ≥1 year to <19 years of age at FIONA EoT and 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 (or local label / guidelines as applicable), unchanged for at least 30 days prior to Visit 1.
5. K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children <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.

Exclusion criteria 14

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 defined according to institutional guidelines on BP management at Visit 1.
4. Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants <18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) <90 mmHg in participants ≥18 years at Visit 1.
5. Known hypersensitivity to the study treatment (active substance or excipients)
6. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
7. Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or prolonged high-dose glucocorticoids (defined as ≥ 0.5 mg/kg/day of prednisolone or equivalent) for more than 7 days
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. Any suspected (S)AE related to the study intervention which led to permanent discontinuation of study intervention during the FIONA study
14. Pregnant or breastfeeding or intention to become pregnant during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Number of participants with treatment emergent adverse events (TEAEs)
2. Change in serum potassium levels from baseline to Day 540±7
3. Change in systolic blood pressure (SBP) from baseline to Day 540±7

Secondary endpoints 2

1. Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
2. Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation

Bayer AG

Address

Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf

City

Leverkusen

Postcode

51373

Country

Germany

Scientific contact point

Organisation

Bayer AG

Contact name

Bayer Clinical Trials Contact

Public contact point

Organisation

Bayer AG

Contact name

Bayer Clinical Trials Contact

Third parties 9

Locations

17 EU/EEA countries · 67 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 405 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications