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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05047263




Registration number
NCT05047263
Ethics application status
Date submitted
12/09/2021
Date registered
17/09/2021
Date last updated
6/10/2021

Titles & IDs
Public title
A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients With Non-Diabetic Chronic Kidney Disease
Secondary ID [1] 0 0
2021-000421-27
Secondary ID [2] 0 0
21177
Universal Trial Number (UTN)
Trial acronym
FIND-CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-diabetic Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo

Experimental: Finerenone (BAY94-8862) - Participants will receive finerenone.

Placebo Comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: Finerenone (BAY94-8862)
Tablet, 10 mg or 20 mg, once daily (OD), oral

Treatment: Drugs: Placebo
Tablet, once daily, oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. - eGFR: Estimated glomerular filtration rate
Timepoint [1] 0 0
From baseline to month 32
Secondary outcome [1] 0 0
Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
Timepoint [1] 0 0
Up to end of study visit (up to approximately 49 months)
Secondary outcome [2] 0 0
Time to the composite of kidney failure or sustained eGFR decline of >= 57%
Timepoint [2] 0 0
Up to end of study visit (up to approximately 49 months)
Secondary outcome [3] 0 0
Time to the composite to heart failure hospitalization or CV death
Timepoint [3] 0 0
Up to end of study visit (up to approximately 49 months)
Secondary outcome [4] 0 0
Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)
Timepoint [4] 0 0
Up to approximately 50 months

Eligibility
Key inclusion criteria
- 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.

- 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

- K+ = 4.8 mmol/L at screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c = 6.5% (48 mmol/mol)

- Autosomal dominant or autosomal recessive polycystic kidney disease

- 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

- Symptomatic heart failure with reduced ejection fraction with class 1A indication for
Mineralocorticoid receptor antagonists (MRAs)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [4] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [5] 0 0
Sunshine Hospital - St. Albans
Recruitment hospital [6] 0 0
Eastern Health Integrated Renal Service - Box Hill
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3073 - Reservoir
Recruitment postcode(s) [5] 0 0
3021 - St. Albans
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney
disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help
people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It
works by blocking a certain hormone called aldosterone that causes injury and inflammation in
the heart and kidney which is known to play a role in CKD.

In this trial, the researchers want to learn if finerenone helps to slow down the worsening
of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial
treatment but does not have any medicine in it. The trial will include about 1,580 men and
women who are at least 18 years old.

The participants will take finerenone or a placebo once a day as tablets by mouth. All of the
participants will also continue to take their current medicine for their CKD. The
participants will be in the trial for up to about 50 months.

During the trial, the doctors will collect blood and urine samples and check the
participants' health. The participants will also answer questions about how they are feeling
and what adverse events they are having. An adverse event is a medical problem that happens
during the trial. Doctors keep track of all adverse events that happen in trials, even if
they do not think the adverse events might be related to the trial treatments.
Trial website
https://clinicaltrials.gov/show/NCT05047263
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05047263