The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect (CAPTIVATE)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Finerenone; Drug: Placebo Finerenone

Detailed Description

Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life.

Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need.

CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.

Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Enmoore Lin; Phone Number: 61 2 8052 4511; Email: captivate@georgeinstitute.org.au

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Recruiting
      • The Canberra Hospital
      • Contact: Girish Talaulikar
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Recruiting
      • Nepean Blue Mountains Local Health District
      • Contact: Bhadran Bose
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Hospital
      • Contact: Sunil Badve
    • New Lambton Heights, New South Wales, Australia, 2305
      • Recruiting
      • John Hunter Hospital
      • Contact: Bobby Chacko
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Vincent Lee
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast Hospital and Health Service
      • Contact: Nicholas Gray
    • Douglas, Queensland, Australia, 4814
      • Recruiting
      • Townsville University Hospital
      • Contact: Vikas Srivastava
    • Ipswich, Queensland, Australia, 4305
      • Recruiting
      • West Moreton Hospital & Health Service
      • Contact: Sree Venuthurupalli
    • Southport, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast Hospital and Health Service
      • Contact: Jagadeesh Kurtkoti
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide
      • Contact: Michael Collins
    • Elizabeth Vale, South Australia, Australia, 5112
      • Recruiting
      • Lyell McEwin Hospital
      • Contact: Nitesh Rao
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Contact: Sharon Ford
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Recruiting
      • South Metropolitan Health Service, Fiona Stanley Hospital
      • Contact: Suda Swaminathan
• India
  • Dehradun, India, 248001
    • Recruiting
    • Max Superspeciality Hospital, Dehradun
    • Contact: Puneet Arora
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530045
      • Recruiting
      • Gitam Institute of Medical Sciences and Research
      • Contact: Murty Mandapaka
  • Bihar
    • Patna, Bihar, India, 800001
      • Recruiting
      • Patna Medical College and Hospital
      • Contact: Harsh Vardhan
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492002
      • Recruiting
      • DKS Super Speciality Hospital, Raipur
      • Contact: Varun Agrawal
  • Dehradun
    • Dehradun, Dehradun, India, 248001
      • Recruiting
      • Mysore Medical College
      • Contact: Puneet Arora
  • Gujarat
    • Ahmedabad, Gujarat, India, 380025
      • Recruiting
      • GCS Medical College, Hospital & Research Centre
      • Contact: Suvika Patel
  • Karnataka
    • Mangaluru, Karnataka, India, 575002
      • Recruiting
      • Father Muller Medical College Hospital
      • Contact: Manjunath Kulkarni
  • Kerala
    • Meppādi, Kerala, India, 673511
      • Recruiting
      • Dr Moopen's Medical College
      • Contact: Aneesh Basheer
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India
      • Recruiting
      • CARE-CHL Hospital
      • Contact: Isha Tiiwari
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600024
      • Recruiting
      • Medway Hospital
      • Contact: Shivakumar Dakshinamoorthy
  • Telangana
    • Hyderabad, Telangana, India, 500084
      • Recruiting
      • Yashoda Hospital Hitec City
      • Contact: Mahesh Kota
    • Hyderabad, Telangana, India
      • Recruiting
      • Apollo Hospitals
      • Contact: Haresh Patel
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Recruiting
      • Charak Hospital and Research Centre
      • Contact: Sakshi Jain
  • Uttarakhand
    • Dehradun, Uttarakhand, India, 248001
      • Recruiting
      • Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital
      • Contact: Gaurav Shekhar Sharma
  • West Bengal
    • Kolkata, West Bengal, India, 700107
      • Recruiting
      • Fortis Hospital
      • Contact: Upal Sengupta
    • Siliguri, West Bengal, India, 734012
      • Recruiting
      • North Bengal Medical College & Hospital
      • Contact: Arpita Ray Chaudhury
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
    • Contact: Dr Helen Pilmore
  • Auckland, New Zealand, 2025
    • Recruiting
    • Aotearoa Clinical Trials Trust, Middlemore Hospital
    • Contact: Kalpa Jayanatha
  • Auckland, New Zealand, 0620
    • Recruiting
    • Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital
    • Contact: Ashik Hayat
  • Dunedin, New Zealand, 9016
    • Recruiting
    • 201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand
    • Contact: John Schollum
  • Whangarei, New Zealand, 0148
    • Recruiting
    • Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand
    • Contact: Adam Mullan
  • Hawkes Bay
    • Hastings, Hawkes Bay, New Zealand, 4120
      • Recruiting
      • Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital
      • Contact: Hussain Allawati
• Spain
  • Espana
    • Valencia, Espana, Spain, 46010
      • Recruiting
      • Hospital Clinico Universitario València (INCLIVA)
      • Contact: Prof Jose Luis Gorriz Teruel
• Sri Lanka
  • Colombo, Sri Lanka, 00700
    • Recruiting
    • National Hospital of Sri Lanka
    • Contact: Dr Mathu Selvarajah
  • Kandy, Sri Lanka, 20000
    • Recruiting
    • Kandy National Hospital
    • Contact: Dr Nishantha Nanayakkara
  • Kurunegala, Sri Lanka
    • Recruiting
    • Kurunegala Teaching Hospital
    • Contact: Dr Premil Rajakrishnan
  • Nugegoda, Sri Lanka, 10250
    • Recruiting
    • Sri Jayewardenepura General Hospital
    • Contact: Dr Harshani Perera
  • Peradeniya, Sri Lanka, 20400
    • Recruiting
    • Peradeniya Teaching Hospital
    • Contact: Dr Rajitha Abeysekera
  • Ragama, Sri Lanka, 11010
    • Recruiting
    • Colombo North Teaching Hospital
    • Contact: Dr Nalaka Herath
  • Polonnaruwa
    • Colombo, Polonnaruwa, Sri Lanka, 51000
      • Recruiting
      • National Nephrology Specialized Hospital
      • Contact: Dr Naseef Thaseem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone; Finerenone 10mg or 20mg tablets	Drug: Finerenone; Finerenone 10mg or 20mg tablets, oral, once daily; Other Names: BAY94-8862
Placebo Comparator: Placebo Finerenone; Finerenone matched placebo tablets	Drug: Placebo Finerenone; Finerenone matched placebo tablets, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR slope	eGFR slope calculated using eGFR values from randomisation to week 108	From randomisation to week 108

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in albuminuria	Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable	From randomisation to week 24
Composite of 40% eGFR decline or kidney failure	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	From randomisation to week 108
All-cause mortality at 108 weeks	Incidence of death from any cause	108 weeks
Number of cardiovascular events	Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)	108 weeks
Safety and tolerability of treatment	Incidence and rates of adverse events, and time from commencement of study treatment until interruption of treatment due to toxicity.	108 weeks
Change in quality of life	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	From randomisation to week 108

Collaborators and Investigators

• Sponsor: The George Institute
• Investigators: Study Chair: Sradha Kotwal, The George Institute; Study Chair: Hiddo Lambers Heerspink, The George Institute

Publications and helpful links

General Publications

• 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.
• Heerspink 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Mineralocorticoid Receptor Antagonist; Finerenone
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; finerenone
• Other Study ID Numbers: P01351; U1111-1324-3113 (Other Identifier: World Health Organisation, Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: TBC
• IPD Sharing Access Criteria: Assessments of data requests will be based on sound science, benefit-risk balancing and research team expertise.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No