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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06058585
Registration number
NCT06058585
Ethics application status
Date submitted
21/09/2023
Date registered
28/09/2023
Date last updated
25/06/2025
Titles & IDs
Public title
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
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Scientific title
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
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Secondary ID [1]
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U1111-1324-3113
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Secondary ID [2]
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P01351
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Universal Trial Number (UTN)
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Trial acronym
CAPTIVATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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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
Treatment: Drugs - Placebo Finerenone
Experimental: Finerenone - Finerenone 10mg or 20mg tablets
Placebo comparator: Placebo Finerenone - Finerenone matched placebo tablets
Treatment: Drugs: Finerenone
Finerenone 10mg or 20mg tablets, oral, once daily
Treatment: Drugs: Placebo Finerenone
Finerenone matched placebo tablets, oral, once daily
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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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eGFR slope
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Assessment method [1]
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eGFR slope calculated using eGFR values from randomisation to week 108
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Timepoint [1]
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From randomisation to week 108
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Secondary outcome [1]
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Change in albuminuria
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Assessment method [1]
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Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable
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Timepoint [1]
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From randomisation to week 24
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Secondary outcome [2]
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Composite of 40% eGFR decline or kidney failure
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Assessment method [2]
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Composite outcome of proportion of participants experiencing a 40% eGFR decline between randomisation and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR \<15 mL/min/1.73m2 or chronic kidney replacement therapy start) at 108 weeks
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Timepoint [2]
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From randomisation to week 108
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Secondary outcome [3]
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All-cause mortality at 108 weeks
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Assessment method [3]
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Incidence of death from any cause
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Timepoint [3]
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108 weeks
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Secondary outcome [4]
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Number of cardiovascular events
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Assessment method [4]
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Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)
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Timepoint [4]
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108 weeks
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Secondary outcome [5]
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Safety and tolerability of treatment
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Assessment method [5]
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Incidence and rates of adverse events, and time from commencement of study treatment until interruption of treatment due to toxicity.
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Timepoint [5]
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108 weeks
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Secondary outcome [6]
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Change in quality of life
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Assessment method [6]
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Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108
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Timepoint [6]
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From randomisation to week 108
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Eligibility
Key inclusion criteria
1. Age = 18 years
2. Known chronic kidney disease from any cause (eGFR =25 mL/min/1.73m2)
3. Currently receiving standard of care treatment according to treating physician
4. Eligible for randomisation in at least one recruiting domain-specific appendix
5. Participant and treating physician are willing and able to perform trial procedures
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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
1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
2. Life expectancy less than 6 months
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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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Factorial
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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
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
4/09/2024
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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
31/03/2029
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Nepean Blue Mountains Local Health District - Kingswood
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Sunshine Coast Hospital and Health Service - Birtinya
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Recruitment hospital [7]
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Townsville University Hospital - Douglas
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Recruitment hospital [8]
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West Moreton Hospital & Health Service - Ipswich
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Recruitment hospital [9]
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Gold Coast Hospital and Health Service - Southport
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Recruitment hospital [10]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [11]
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Austin Health - Heidelberg
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Recruitment hospital [12]
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South Metropolitan Health Service, Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2305 - New Lambton Heights
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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4575 - Birtinya
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Recruitment postcode(s) [7]
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4814 - Douglas
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Recruitment postcode(s) [8]
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4305 - Ipswich
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Recruitment postcode(s) [9]
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4215 - Southport
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Recruitment postcode(s) [10]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [11]
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3084 - Heidelberg
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Andra Pradesh
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Country [2]
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India
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State/province [2]
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Bihar
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Country [3]
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India
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State/province [3]
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Karnataka
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Country [4]
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India
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State/province [4]
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Kerala
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Country [5]
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India
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State/province [5]
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Madhya Pradesh
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Country [6]
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India
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State/province [6]
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Tamil Nadu
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Country [7]
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India
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State/province [7]
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Telangana
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Country [8]
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India
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State/province [8]
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Uttar Pradesh
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Country [9]
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India
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State/province [9]
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Uttarakhand
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Country [10]
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India
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State/province [10]
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West Bengal
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Country [11]
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New Zealand
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State/province [11]
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Hawkes Bay
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Country [12]
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New Zealand
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State/province [12]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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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
CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.
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Trial website
https://clinicaltrials.gov/study/NCT06058585
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sradha Kotwal
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Enmoore Lin
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Address
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Country
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Phone
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61 2 8052 4511
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06058585
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