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Clinical Trial Details

Trial ID: L0018
Source ID: NCT06058585
Associated Drug: Finerenone
Title: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Acronym: CAPTIVATE
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Finerenone|DRUG: Placebo Finerenone
Outcome Measures: 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|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
Sponsor/Collaborators: Sponsor: The George Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-04
Completion Date: 2028-12-31
Results First Posted:
Last Update Posted: 2024-11-21
Locations: The Canberra Hospital, Garran, Australian Capital Territory, 2605, Australia|St George Hospital, Kogarah, New South Wales, 2217, Australia|John Hunter Hospital, New Lambton Heights, New South Wales, 2305, Australia|Westmead Hospital, Westmead, New South Wales, 2145, Australia|Sunshine Coast Hospital and Health Service, Birtinya, Queensland, 4575, Australia|West Moreton Hospital & Health Service, Ipswich, Queensland, 4305, Australia|Gold Coast Hospital and Health Service, Southport, Queensland, 4215, Australia|Lyell McEwin Hospital, Elizabeth Vale, South Australia, 5112, Australia|Austin Health, Heidelberg, Victoria, 3084, Australia|Gitam Institute of Medical Sciences and Research, Visakhapatnam, Andra Pradesh, 530045, India|Dr Moopen's Medical College, Wayanad, Kerala, 673511, India|Medway Hospital, Chennai, Tamil Nadu, 600024, India|North Bengal Medical College & Hospital, Siliguri, West Bengal, 734012, India
URL: https://clinicaltrials.gov/show/NCT06058585