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NCT Number: NCT06058585

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Canberra Hospital, Garran, Australian Capital Territory, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
  • Life expectancy less than 6 months

Treatment and study plan

Finerenone

Drug

Finerenone 10mg or 20mg tablets, oral, once daily

Other names: BAY94-8862

Placebo Finerenone

Drug

Finerenone matched placebo tablets, oral, once daily

Primary outcomes

  1. eGFR slope

    Time frame: From randomisation to week 108

    eGFR slope calculated using eGFR values from randomisation to week 108

Secondary outcomes

  1. 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

  2. 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

  3. All-cause mortality at 108 weeks

    Time frame: 108 weeks

    Incidence of death from any cause

  4. Number of cardiovascular events

    Time frame: 108 weeks

    Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)

  5. 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.

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Enmoore Lin

CONTACT

[email protected]

61 2 8052 4511

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Registry information

Acronym: CAPTIVATE

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 28, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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