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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
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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
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Secondary ID [1]
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2021-000421-27
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Secondary ID [2]
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21177
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Universal Trial Number (UTN)
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Trial acronym
FIND-CKD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-diabetic Chronic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
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Assessment method [1]
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eGFR: Estimated glomerular filtration rate
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Timepoint [1]
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From baseline to month 32
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Secondary outcome [1]
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Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
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Assessment method [1]
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Timepoint [1]
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Up to end of study visit (up to approximately 49 months)
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Secondary outcome [2]
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Time to the composite of kidney failure or sustained eGFR decline of >= 57%
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Assessment method [2]
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Timepoint [2]
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Up to end of study visit (up to approximately 49 months)
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Secondary outcome [3]
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Time to the composite to heart failure hospitalization or CV death
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Assessment method [3]
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Timepoint [3]
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Up to end of study visit (up to approximately 49 months)
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Secondary outcome [4]
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Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)
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Assessment method [4]
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Timepoint [4]
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Up to approximately 50 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/02/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1584
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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St George Hospital - Kogarah
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Illawarra Shoalhaven Local Health District - Wollongong
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Sunshine Coast University Hospital - Birtinya
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Melbourne Renal Research Group - Reservoir
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Sunshine Hospital - St. Albans
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Eastern Health Integrated Renal Service - Box Hill
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Recruitment hospital [8]
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Princess Alexandra Hospital Australia - Woolloongabba
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Recruitment postcode(s) [1]
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2139 - Concord
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2217 - Kogarah
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2500 - Wollongong
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4575 - Birtinya
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Recruitment postcode(s) [5]
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3073 - Reservoir
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3021 - St. Albans
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3128 - Box Hill
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Recruitment postcode(s) [8]
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4102 - Woolloongabba
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Recruitment outside Australia
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Japan
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State/province [129]
0
0
Chiba
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Country [130]
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Japan
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State/province [130]
0
0
Fukuoka
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Country [131]
0
0
Japan
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State/province [131]
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0
Gifu
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Country [132]
0
0
Japan
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State/province [132]
0
0
Hyogo
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Japan
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State/province [133]
0
0
Ibaraki
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Japan
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State/province [134]
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0
Ishikawa
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0
Japan
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State/province [135]
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0
Iwate
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Japan
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State/province [136]
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Kanagawa
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Japan
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State/province [137]
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0
Nagano
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Japan
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State/province [138]
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0
Okayama
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Country [139]
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Japan
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State/province [139]
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Osaka
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Japan
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State/province [140]
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0
Saitama
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Japan
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State/province [141]
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Shizuoka
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Japan
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State/province [142]
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Tokyo
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Country [143]
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Japan
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State/province [143]
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0
Yamanashi
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Japan
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Kumamoto
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Japan
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Nara
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Japan
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Saga
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Korea, Republic of
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Gang''weondo
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Korea, Republic of
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State/province [148]
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Gyeonggido
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Korea, Republic of
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State/province [149]
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Incheon Gwang''yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Korea, Republic of
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Busan
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Korea, Republic of
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Daejeon
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Gyeonggi-do
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Malaysia
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Selangor
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Malaysia
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Kedah
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Malaysia
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Kuala Lumpur
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Malaysia
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Muar
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Malaysia
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Negeri Sembilan
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Malaysia
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Pahang
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Malaysia
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Perak
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Malaysia
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Pulau Pinang
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Mexico
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Aguascalientes
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Mexico
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Sinaloa
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Mexico
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Veracruz
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Portugal
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Lisboa
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Portugal
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Santarém
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Portugal
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Setúbal
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Portugal
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Leiria
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Russian Federation
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Arkhangelsk
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Russian Federation
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Izhevsk
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Sestroretsk
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Russian Federation
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Voronezh
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Russian Federation
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Yaroslavl
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Singapore
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Singapore
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Hsinchu
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Taiwan
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Taipei
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Taiwan
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Changhua
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Taiwan
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State/province [190]
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taoyuan
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United Kingdom
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Kent
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United Kingdom
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South Yorkshire
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United Kingdom
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Cardiff
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United Kingdom
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Gloucester
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05047263
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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