A study to learn how well the study treatment finerenone works and how safe it is in people with long-term decrease in the kidneys’ ability to work properly (chronic kidney disease) together with type 1 diabetes

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

27 Feb 2024 → 16 Sep 2025

Decision date (initial)

2023-10-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bayer AG, Leverkusen, Germany

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacogenetic

To demonstrate that finerenone in addition to SoC is superior to placebo in reducing UACR over 6 months in participants with CKD and T1D

Secondary objectives 1

1. To assess the safety of finerenone in addition to SoC compared to placebo

Conditions and MedDRA coding

Chronic kidney disease associated with type 1 diabetes mellitus

Study design 1 period

Regulatory references

Scientific advice from competent authorities

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 6

1. Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
2. Participants with T1D, i.e. T1D continuously treated with insulin, started within one year from diagnosis.
3. HbA1c at Screening <10% (central assessment). Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
4. K+ ≤ 4.8 mmol/L at Screening (local assessment)
5. "Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): - eGFR ≥25 and <90 mL/min/1.73 m2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit - UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) "
6. Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.

Exclusion criteria 4

1. Participant with T2D (Type 2 diabetes).
2. Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
3. Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 receptor agonist.
4. Previous assignment to study intervention during this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in UACR from baseline (ratio to baseline) over 6 months

Secondary endpoints 1

1. Number of participants with TEAEs, TESAEs and Hyperkalaemia (AESI)

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation

Bayer AG

City

Leverkusen

Postcode

51368

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 4

Locations

4 EU/EEA countries · 23 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 45 files

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

Application history

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