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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

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
Treatment: Drugs - Endothelin Receptor Antagonist
Treatment: Drugs - Placebo Endothelin Receptor Antagonist

Experimental: Finerenone - Finerenone 10mg or 20mg tablets

Placebo comparator: Placebo Finerenone - Finerenone matched placebo tablets

Experimental: Endothelin Receptor Antagonist - Endothelin Receptor Antagonist tablets

Placebo comparator: Placebo Endothelin Receptor Antagonist - Placebo Endothelin Receptor Antagonist tablets


Treatment: Drugs: Finerenone
Finerenone 10mg or 20mg tablets, oral, once daily

Treatment: Drugs: Placebo Finerenone
Finerenone matched placebo tablets, oral, once daily

Treatment: Drugs: Endothelin Receptor Antagonist
Endothelin Receptor Antagonist tablets, oral, once daily

Treatment: Drugs: Placebo Endothelin Receptor Antagonist
Placebo Endothelin Receptor Antagonist 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
19/08/2024
Actual
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)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
captivate@georgeinstitute.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Trial data will be made available as a resource for future unspecified research, subject to any prior contractual obligations. Researchers wishing to gain access to the study resources will be required to submit an application for review by the Platform Oversight Committee, including a detailed project description, a list of data requested, and evidence of ethical approval. De-identified data extracts will be made available to approved proposals, and will not include data obtained from data linkage with local registries.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
TBC
Available to whom?
Assessments of data requests will be based on sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
How or where can data be obtained?


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