Clinical trial NCT06058585: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Official title: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Kidney Diseases
Keywords: Chronic kidney disease
Mineralocorticoid Receptor Antagonist
Finerenone
Lead sponsor: The George Institute
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: eGFR slope
timeFrame: From randomisation to week 108
Secondary outcomes:
measure: Change in albuminuria
timeFrame: From randomisation to week 24
measure: Composite of 40% eGFR decline or kidney failure
timeFrame: From randomisation to week 108
measure: All-cause mortality at 108 weeks
timeFrame: 108 weeks
measure: Number of cardiovascular events
timeFrame: 108 weeks
measure: Safety and tolerability of treatment
timeFrame: 108 weeks
measure: Change in quality of life
timeFrame: From randomisation to week 108
Other outcomes:
Locations:
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Kingswood
country: Australia
facility: Nepean Blue Mountains Local Health District
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast Hospital and Health Service
state: Queensland
city: Douglas
country: Australia
facility: Townsville University Hospital
state: Queensland
city: Ipswich
country: Australia
facility: West Moreton Hospital & Health Service
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Murdoch
country: Australia
facility: South Metropolitan Health Service, Fiona Stanley Hospital
state: Western Australia
city: Visakhapatnam
country: India
facility: Gitam Institute of Medical Sciences and Research
state: Andra Pradesh
city: Patna
country: India
facility: Patna Medical College and Hospital
state: Bihar
city: Mangaluru
country: India
facility: Father Muller Medical College Hospital
state: Karnataka
city: Meppadi
country: India
facility: Dr Moopen's Medical College
state: Kerala
city: Indore
country: India
facility: CARE-CHL Hospital
state: Madhya Pradesh
city: Chennai
country: India
facility: Medway Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Yashoda Hospital Hitec City
state: Telangana
city: Hyderabad
country: India
facility: Apollo Hospitals
state: Telangana
city: Lucknow
country: India
facility: Charak Hospital and Research Centre
state: Uttar Pradesh
city: Dehradun
country: India
facility: Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital
state: Uttarakhand
city: Kolkata
country: India
facility: Fortis Hospital
state: West Bengal
city: Siliguri
country: India
facility: North Bengal Medical College & Hospital
state: West Bengal
city: Hastings
country: New Zealand
facility: Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital
state: Hawkes Bay
city: Auckland
country: New Zealand
facility: Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials Trust, Middlemore Hospital
Study officials:
affiliation: The George Institute
name: Sradha Kotwal
role: STUDY_CHAIR
affiliation: The George Institute
name: Hiddo Lambers Heerspink
role: STUDY_CHAIR
References: