A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

18 Oct 2021 → 3 Feb 2026

Decision date (initial)

2024-04-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bayer AG

External identifiers

EU CT number

2023-506897-11-00

EudraCT number

2021-000421-27

ClinicalTrials.gov

NCT05047263

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacogenetic, Efficacy, Pharmacokinetic

To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease.

Secondary objectives 2

1. To demonstrate the beneficial effect of finerenone in addition to SoC as compared to placebo.
2. To assess the safety of finerenone in addition to SoC as compared to placebo.

Conditions and MedDRA coding

Non-diabetic chronic kidney disease

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

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 3

1. A clinical diagnosis of chronic kidney disease and: • Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥25 but <90 mL/min/1.73m^2 at screening, and • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.
2. Stable and maximum tolerated labeled dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening
3. K+ ≤ 4.8 mmol/L at screening

Exclusion criteria 4

1. Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)
2. Autosomal dominant or autosomal recessive polycystic kidney disease
3. 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
4. Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.

Secondary endpoints 4

1. Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
2. Time to the composite of kidney failure or sustained eGFR decline of >=57%
3. Time to the composite to heart failure hospitalization or CV death
4. Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)

Investigational products

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

Test 2

Placebo 2

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

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 7

Locations

9 EU/EEA countries · 64 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 81 files

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

Application history

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