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

Chronic Kidney Diseases Clinical Trial

— CAPTIVATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06058585
• Other study ID #: P01351
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 15, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: The George Institute
• Contact: Enmoore Lin
• Phone: 61 2 8052 4511
• Email: captivate[@]georgeinstitute.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: August 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Finerenone
Finerenone 10mg or 20mg tablets, oral, once daily
• Placebo Finerenone
Finerenone matched placebo tablets, oral, once daily
• Endothelin Receptor Antagonist
Oral, once daily
• Placebo Endothelin Receptor Antagonist
Oral, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The George Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR slope	eGFR slope calculated using eGFR values from randomisation to week 108	From randomisation to week 108
Secondary	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
Secondary	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
Secondary	All-cause mortality at 108 weeks	Incidence of death from any cause	108 weeks
Secondary	Number of cardiovascular events	Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)	108 weeks
Secondary	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
Secondary	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