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

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ClinicalTrials.gov Identifier: NCT06058585
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : April 19, 2024
Sponsor:
Information provided by (Responsible Party):
The George Institute

Tracking Information
First Submitted Date  ICMJE September 21, 2023
First Posted Date  ICMJE September 28, 2023
Last Update Posted Date April 19, 2024
Estimated Study Start Date  ICMJE June 15, 2024
Estimated Primary Completion Date August 30, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2023)		 eGFR slope [ Time Frame: From randomisation to week 108 ]
eGFR slope calculated using eGFR values from randomisation to week 108
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2023)
  • Change in albuminuria [ Time Frame: From randomisation to week 24 ]
    Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable
  • Composite of 40% eGFR decline or kidney failure [ Time Frame: From randomisation to week 108 ]
    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
  • All-cause mortality at 108 weeks [ Time Frame: 108 weeks ]
    Incidence of death from any cause
  • Number of cardiovascular events [ Time Frame: 108 weeks ]
    Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)
  • Safety and tolerability of treatment [ Time Frame: 108 weeks ]
    Incidence and rates of adverse events, and time from commencement of study treatment until interruption of treatment due to toxicity.
  • Change in quality of life [ Time Frame: From randomisation to week 108 ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Official Title  ICMJE The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Adaptive platform trial evaluating multiple interventions in multiple domains of therapeutic care. Additional interventions and participants will be added as the trial grows.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Diseases
Intervention  ICMJE
  • Drug: Finerenone
    Finerenone 10mg or 20mg tablets, oral, once daily
    Other Name: BAY94-8862
  • Drug: Placebo Finerenone
    Finerenone matched placebo tablets, oral, once daily
  • Drug: Endothelin Receptor Antagonist
    Oral, once daily
  • Drug: Placebo Endothelin Receptor Antagonist
    Oral, once daily
Study Arms  ICMJE
  • Experimental: Finerenone
    Finerenone 10mg or 20mg tablets
    Intervention: Drug: Finerenone
  • Placebo Comparator: Placebo Finerenone
    Finerenone matched placebo tablets
    Intervention: Drug: Placebo Finerenone
  • Experimental: Endothelin Receptor Antagonist
    Intervention: Drug: Endothelin Receptor Antagonist
  • Placebo Comparator: Placebo Endothelin Receptor Antagonist
    Intervention: Drug: Placebo Endothelin Receptor Antagonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2023)		 1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2028
Estimated Primary Completion Date August 30, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enmoore Lin 61 2 8052 4511 captivate@georgeinstitute.org.au
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06058585
Other Study ID Numbers  ICMJE P01351
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: TBC
Access Criteria: Assessments of data requests will be based on sound science, benefit-risk balancing and research team expertise.
Current Responsible Party The George Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The George Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sradha Kotwal The George Institute
Study Chair: Hiddo Lambers Heerspink The George Institute
PRS Account The George Institute
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP