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

• Sponsor: The George Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06058585
• Collaborator: (none)
• Enrollment: 1,000
• Arms: 2
• Anticipated Duration (Months): 55.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Drug: Mineralocorticoid receptor antagonist; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• 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.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
• Official Title: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
• Anticipated Study Start Date: May 15, 2024
• Anticipated Primary Completion Date: Jun 30, 2028
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mineralocorticoid receptor antagonist Mineralocorticoid receptor antagonist	Drug: Mineralocorticoid receptor antagonist; Oral, once daily
Placebo Comparator: Placebo Placebo	Drug: Placebo; Matched placebo tablets, oral, once daily

Outcome Measures

Primary Outcome Measures

1. eGFR slope [From randomisation to week 108]

   eGFR slope calculated using eGFR values from randomisation to week 108

Secondary Outcome Measures

1. Change in albuminuria [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 [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 [108 weeks]

   Incidence of death from any cause

4. Number of cardiovascular events [108 weeks]

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

5. Safety and tolerability of treatment [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The George Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The George Institute
• ClinicalTrials.gov Identifier: NCT06058585
• Other Study ID Numbers: P01351
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The George Institute: Chronic kidney disease; Mineralocorticoid Receptor Antagonist
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Mineralocorticoid Receptor Antagonists; Mineralocorticoids

Study Results

No Results Posted as of Sep 28, 2023