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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05047263
Ethics application status
Date submitted
12/09/2021
Date registered
17/09/2021

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.
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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/02/2026
Actual
Sample size
Target
Accrual to date
Final
1584
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [6] 0 0
Sunshine Hospital - St. Albans
Recruitment hospital [7] 0 0
Eastern Health Integrated Renal Service - Box Hill
Recruitment hospital [8] 0 0
Princess Alexandra Hospital Australia - Woolloongabba
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
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
3073 - Reservoir
Recruitment postcode(s) [6] 0 0
3021 - St. Albans
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05047263