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

Conditions

Chronic Kidney Disease

Brief summary

Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104

Detailed description

Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable, 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/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks, Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure, All-cause mortality at 108 weeks, Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks, Time to first occurrence of a cardiovascular event, Safety and tolerability of treatment, 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, The Mineralocorticoid Receptor Antagonist Domain-Specific Appendix has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure, Change in eGFR from randomisation to end of washout

Related papers

No related papers found yet.

Interventions

DRUGPlacebo coated tablet 002 to bay 948862 coated tablet

DRUGKerendia 20 mg film-coated tablets

DRUGKerendia 10 mg film coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104	—

Secondary

Measure	Time frame
Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable, 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/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks, Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure, All-cause mortality at 108 weeks, Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks, Time to first occurrence of a cardiovascular event, Safety and tolerability of treatment, 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, The Mineralocorticoid R	—

Measure

Time frame

Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable, 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/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks, Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure, All-cause mortality at 108 weeks, Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks, Time to first occurrence of a cardiovascular event, Safety and tolerability of treatment, 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, The Mineralocorticoid R

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Countries

Spain

Outcome results

None listed