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Finerenone (BAY94-8862) for Chronic Kidney Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Zhujiang Hospital of Southern Medical University, Guangzhou, ChinaChronic Kidney DiseaseFinerenone (BAY94-8862) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is being done to find out if the drug finerenone helps people with non-diabetic CKD.

Eligible Conditions
  • Chronic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to approximately 50 months

Month 32
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
Month 50
Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)
Month 49
Time to the composite of kidney failure or sustained eGFR decline of >= 57%
Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
Time to the composite to heart failure hospitalization or CV death

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
air filtration with hepa filter
2
VX-147
2
Baricitinib

Side Effects for

Finerenone
15%Hyperkalaemia
9%Nasopharyngitis
7%Anaemia
7%Hypertension
6%Glomerular filtration rate decreased
6%Diarrhoea
6%Upper respiratory tract infection
6%Urinary tract infection
6%Back pain
6%Oedema peripheral
5%Constipation
5%Hypoglycaemia
5%Arthralgia
5%Dizziness
4%Bronchitis
2%Pneumonia
2%Acute kidney injury
1%Hyperglycaemia
1%Sepsis
1%Diabetic nephropathy
1%Cataract
1%Cellulitis
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02540993) in the Finerenone ARM group. Side effects include: Hyperkalaemia with 15%, Nasopharyngitis with 9%, Anaemia with 7%, Hypertension with 7%, Glomerular filtration rate decreased with 6%.

Trial Design

2 Treatment Groups

Finerenone (BAY94-8862)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

1580 Total Participants · 2 Treatment Groups

Primary Treatment: Finerenone (BAY94-8862) · Has Placebo Group · Phase 3

Finerenone (BAY94-8862)
Drug
Experimental Group · 1 Intervention: Finerenone (BAY94-8862) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finerenone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 50 months

Who is running the clinical trial?

BayerLead Sponsor
2,158 Previous Clinical Trials
23,876,010 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
North Carolina33.3%
Texas33.3%
Missouri33.3%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
St. Louis Heart & Vascular, PC100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
References

Frequently Asked Questions

To the best of your knowledge, is this research project without precedent?

"Finerenone (BAY94-8862), which was first studied in 2020, has had 2 clinical trials since then. The first one was sponsored by Bayer and occurred in 2020. After the initial Phase 3 drug approval 6000 people were enrolled. The second trial is currently ongoing and involves 448 cities across 39 countries." - Anonymous Online Contributor

Unverified Answer

For what standard medical condition is Finerenone (BAY94-8862) prescribed?

"Finerenone (BAY94-8862) is a medication with multiple uses. It is commonly used to treat cardiovascular mortality, but can also be given to patients suffering from heart failure, type 2 diabetes mellitus, and myocardial infarction." - Anonymous Online Contributor

Unverified Answer

Has Finerenone (BAY94-8862) received FDA sanctioning?

"Finerenone (BAY94-8862) has received a safety rating of 3. This is because Phase 3 trials, of which this medication is currently undergoing, have yielded some evidence of efficacy as well as multiple rounds data affirming its safety." - Anonymous Online Contributor

Unverified Answer

Are there other instances where Finerenone (BAY94-8862) has been tested in a controlled setting?

"There are currently two Phase 3 trials underway for Finerenone (BAY94-8862), with a total of 1205 study sites worldwide." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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