The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
CAPTIVATE
2 other identifiers
interventional
1,000
5 countries
43
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2024
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
April 1, 2026
May 1, 2025
4 years
September 21, 2023
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
eGFR slope
eGFR slope calculated using eGFR values from randomisation to week 108
From randomisation to week 108
Secondary Outcomes (6)
Change in albuminuria
From randomisation to week 24
Composite of 40% eGFR decline or kidney failure
From randomisation to week 108
All-cause mortality at 108 weeks
108 weeks
Number of cardiovascular events
108 weeks
Safety and tolerability of treatment
108 weeks
- +1 more secondary outcomes
Study Arms (2)
Finerenone
EXPERIMENTALFinerenone 10mg or 20mg tablets
Placebo Finerenone
PLACEBO COMPARATORFinerenone matched placebo tablets
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
- Currently receiving standard of care treatment according to treating physician
- Eligible for randomisation in at least one recruiting domain-specific appendix
- Participant and treating physician are willing and able to perform trial procedures
You may not qualify if:
- Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
- Life expectancy less than 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Nepean Blue Mountains Local Health District
Kingswood, New South Wales, 2747, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, 4575, Australia
Townsville University Hospital
Douglas, Queensland, 4814, Australia
West Moreton Hospital & Health Service
Ipswich, Queensland, 4305, Australia
Gold Coast Hospital and Health Service
Southport, Queensland, 4215, Australia
Royal Adelaide
Adelaide, South Australia, 5000, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
South Metropolitan Health Service, Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Gitam Institute of Medical Sciences and Research
Visakhapatnam, Andhra Pradesh, 530045, India
Patna Medical College and Hospital
Patna, Bihar, 800001, India
DKS Super Speciality Hospital, Raipur
Raipur, Chhattisgarh, 492002, India
Mysore Medical College
Dehradun, Dehradun, 248001, India
GCS Medical College, Hospital & Research Centre
Ahmedabad, Gujarat, 380025, India
Father Muller Medical College Hospital
Mangaluru, Karnataka, 575002, India
Dr Moopen's Medical College
Meppādi, Kerala, 673511, India
CARE-CHL Hospital
Indore, Madhya Pradesh, India
Medway Hospital
Chennai, Tamil Nadu, 600024, India
Yashoda Hospital Hitec City
Hyderabad, Telangana, 500084, India
Apollo Hospitals
Hyderabad, Telangana, India
Charak Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003, India
Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 248001, India
Fortis Hospital
Kolkata, West Bengal, 700107, India
North Bengal Medical College & Hospital
Siliguri, West Bengal, 734012, India
Max Superspeciality Hospital, Dehradun
Dehradun, 248001, India
Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital
Hastings, Hawkes Bay, 4120, New Zealand
Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital
Auckland, 0620, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Aotearoa Clinical Trials Trust, Middlemore Hospital
Auckland, 2025, New Zealand
201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand
Dunedin, 9016, New Zealand
Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand
Whangarei, 0148, New Zealand
Hospital Clinico Universitario València (INCLIVA)
Valencia, Espana, 46010, Spain
National Nephrology Specialized Hospital
Colombo, Polonnaruwa, 51000, Sri Lanka
National Hospital of Sri Lanka
Colombo, 00700, Sri Lanka
Kandy National Hospital
Kandy, 20000, Sri Lanka
Kurunegala Teaching Hospital
Kurunegala, Sri Lanka
Sri Jayewardenepura General Hospital
Nugegoda, 10250, Sri Lanka
Peradeniya Teaching Hospital
Peradeniya, 20400, Sri Lanka
Colombo North Teaching Hospital
Ragama, 11010, Sri Lanka
Related Publications (2)
Kotwal SS, Perkovic V, Jardine MJ, Kim D, Shah NA, Lin E, Coggan S, Billot L, Vart P, Wheeler DC, de Boer IH, Zhang H, Hou FF, Sugawara Y, Marion J, Lewis RJ, Berry LR, McGlothlin A, Jha V, De Nicola L, Gorriz JL, Heerspink HJL; GKPTN and CAPTIVATE Investigators. The Global Kidney Patient Trials Network and the CAPTIVATE Platform Clinical Trial Design: A Trial Protocol. JAMA Netw Open. 2024 Dec 2;7(12):e2449998. doi: 10.1001/jamanetworkopen.2024.49998.
PMID: 39661388DERIVEDHeerspink HJL, Kretzler M. Clinical Trials for Kidney Disease in the Era of Personalized Medicine. J Am Soc Nephrol. 2024 Aug 1;35(8):1123-1126. doi: 10.1681/ASN.0000000000000412. Epub 2024 May 9. No abstract available.
PMID: 39248631DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sradha Kotwal
The George Institute
- STUDY CHAIR
Hiddo Lambers Heerspink
The George Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The default position within CAPTIVATE is that treatment allocations determined by randomisation will be provided on a blinded basis. Blinding, however, may not always be feasible particularly for behavioural or device-related interventions.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
September 4, 2024
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
April 1, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- TBC
- Access Criteria
- Assessments of data requests will be based on sound science, benefit-risk balancing and research team expertise.
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.