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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
21/11/2024

Titles & IDs
Public title
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Scientific title
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Secondary ID [1] 0 0
P01351
Universal Trial Number (UTN)
Trial acronym
CAPTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases 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
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
eGFR slope
Timepoint [1] 0 0
From randomisation to week 108
Secondary outcome [1] 0 0
Change in albuminuria
Timepoint [1] 0 0
From randomisation to week 24
Secondary outcome [2] 0 0
Composite of 40% eGFR decline or kidney failure
Timepoint [2] 0 0
From randomisation to week 108
Secondary outcome [3] 0 0
All-cause mortality at 108 weeks
Timepoint [3] 0 0
108 weeks
Secondary outcome [4] 0 0
Number of cardiovascular events
Timepoint [4] 0 0
108 weeks
Secondary outcome [5] 0 0
Safety and tolerability of treatment
Timepoint [5] 0 0
108 weeks
Secondary outcome [6] 0 0
Change in quality of life
Timepoint [6] 0 0
From randomisation to week 108

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
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
4/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [6] 0 0
West Moreton Hospital & Health Service - Ipswich
Recruitment hospital [7] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment hospital [8] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4305 - Ipswich
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Andra Pradesh
Country [2] 0 0
India
State/province [2] 0 0
Kerala
Country [3] 0 0
India
State/province [3] 0 0
Tamil Nadu
Country [4] 0 0
India
State/province [4] 0 0
West Bengal

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06058585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sradha Kotwal
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Enmoore Lin
Address 0 0
Country 0 0
Phone 0 0
61 2 8052 4511
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06058585