Finerenone for Chronic Kidney Disease and Type 2 Diabetes

Recruiting at 67 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bayer

Must be taking: Finerenone

Disqualifiers: Other trials, Contra-indications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

4500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about how people with chronic kidney disease (CKD) and type 2 diabetes (T2D) use the drug finerenone (also known as Kerendia) in their regular medical care. Researchers seek to understand treatment patterns, such as why patients start or stop taking finerenone, and any side effects they may experience. The study also examines how often high potassium levels occur, especially when combined with other blood pressure medications. People with CKD and T2D who have recently started taking finerenone or plan to start soon might be suitable for this study. Participants will be observed for up to 12 months, with data collected from medical records and interviews during routine doctor visits. As a Phase 4 trial, this study focuses on understanding how the already FDA-approved and effective finerenone benefits more patients, offering participants a chance to contribute to broader knowledge about its use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It seems you can continue other medications while taking finerenone, but you should discuss this with your doctor.

What is the safety track record for finerenone?

Research has shown that finerenone is generally safe for people with chronic kidney disease (CKD) and type 2 diabetes (T2D). Studies have found that this medication can lower the risk of kidney and heart issues without causing serious side effects. However, hyperkalemia, or elevated potassium levels in the blood, is a common concern with finerenone. This risk increases when finerenone is taken with certain blood pressure medicines.

In past studies, most patients tolerated finerenone well, but some experienced higher potassium levels. Patients should work closely with their doctors to monitor potassium levels and address any potential issues. Overall, while finerenone is approved for use and considered safe, monitoring is crucial to ensure it works effectively in each patient's regular care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Finerenone is unique because it targets mineralocorticoid receptors, which play a key role in inflammation and fibrosis in the kidneys and heart. Most treatments for chronic kidney disease (CKD) and type 2 diabetes (T2D) focus on controlling blood pressure and blood sugar levels. However, finerenone offers a new approach by directly addressing the underlying cellular damage that contributes to disease progression. Researchers are excited about this treatment as it has the potential to offer better protection for kidney and heart health in patients with CKD and T2D, potentially slowing down disease progression more effectively than current options.

What is the effectiveness track record for finerenone in treating CKD and T2D?

Research has shown that finerenone benefits people with chronic kidney disease (CKD) and type 2 diabetes (T2D). Studies have found that it reduces the risk of CKD progression and lowers heart-related problems. In patients with CKD and T2D, finerenone consistently decreased kidney issues and hospital visits for heart failure. It also reduced the chances of major heart events and death from any cause. Finerenone works by blocking certain proteins that can harm the kidneys and heart when overly active. Its approval for these conditions proves its effectiveness in treating CKD and T2D. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with Chronic Kidney Disease associated with Type 2 Diabetes by a medical professional.

Treatment with finerenone 20 or 10 mg, according to local marketing authorization, should have commenced within 8 weeks prior to or after the ICF is signed.

You have provided signed consent for participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone as part of their routine medical care for CKD and T2D

12 months

Visits during routine medical care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Finerenone

How Is the Trial Designed?

Group I: Participants diagnosed with CKD and T2D Experimental Treatment 1 Intervention

Participants who are newly prescribed finerenone under routine treatment conditions.

Finerenone is already approved in United States, European Union for the following indications:

Approved in United States as Kerendia for:

• Chronic kidney disease associated with type 2 diabetes

Approved in European Union as Kerendia for:

• Chronic kidney disease associated with type 2 diabetes

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2025845

Effect of Finerenone on Chronic Kidney Disease Outcomes ... In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33264825/

Effect of Finerenone on Chronic Kidney Disease Outcomes ... In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events ...

3. natap.org natap.org/2025/HIV/NEJMoa2025845.pdf

Effect of Finerenone on Chronic Kidney Disease Outcomes ... In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo.

4. diabetesjournals.org diabetesjournals.org/care/article/48/5/745/157943/Efficacy-and-Safety-of-Finerenone-in-Type-2

Efficacy and Safety of Finerenone in Type 2 Diabetes: A ... Finerenone consistently reduced the kidney composite outcome, HF hospitalization, major adverse cardiovascular events, and all-cause mortality, ...

5. nature.com nature.com/articles/s41591-024-03264-4

Finerenone in heart failure and chronic kidney disease with ... Finerenone has been shown to reduce the risk of cardiovascular events and kidney failure in patients with CKD with type 2 diabetes (T2D) and has ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35034019/

Meta-Analysis of the Efficacy and Safety of Finerenone in ... Finerenone contributes to the reduction of UACR and can ameliorate the deterioration of renal function in patients with T2D and CKD.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02540993

NCT02540993 | Efficacy and Safety of Finerenone in ... The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf

215341Orig1s000 - accessdata.fda.gov chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone does not lower arterial blood pressure at doses that slow the progression ...