CAPTIVATE: Finding treatments to slow the progression of chronic kidney disease
Background
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 treatments that can slow CKD progression.
Aim
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 is the first platform trial in CKD and will identify the best treatments for CKD more quickly than with traditional trial designs, thus saving time and money.
Research Methodology
CAPTIVATE is a multi-centre, phase III, adaptive, platform, randomised controlled trial. It uses a design that can answer many treatment-related questions within a common trial set-up. 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 includes blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.
CAPTIVATE will begin by testing whether a mineralocorticoid receptor antagonist slows the progression of CKD when compared to placebo. 1000 participants will be recruited globally from over 50 sites in Australia, New Zealand, India and Italy. Additional treatments, participants, countries and sites will be added as the trial grows.
