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: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Finerenone; Drug: Placebo Finerenone; Drug: Endothelin Receptor Antagonist; Drug: Placebo Endothelin Receptor Antagonist

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

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

4

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
Experimental: Endothelin Receptor Antagonist	Drug: Endothelin Receptor Antagonist; Oral, once daily
Placebo Comparator: Placebo Endothelin Receptor Antagonist	Drug: Placebo Endothelin Receptor Antagonist; 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

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): December 31, 2028

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 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Mineralocorticoid Receptor Antagonist; Finerenone
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Endothelin Receptor Antagonists
• Other Study ID Numbers: P01351

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