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Landmark CREDENCE renal outcomes trial stopped early based on achievement of pre-specified efficacy criteria.

SITUATION

Five million people are predicted to have kidney failure by 2035. This is a global problem causing not only a diminished quality of life for patients, who are at risk for many adverse health outcomes, but also creating great societal and financial costs worldwide. Finding better ways to try and improve those outcomes, or more importantly, prevent people from reaching kidney failure, has been a real passion for the scientific leadership teams at George Clinical and The George Institute of Global Health for over 20 years, and it’s an area where we have seen some real success.

CREDENCE was the first dedicated renal outcomes trial in patients with chronic kidney disease and type 2 diabetes. This randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial evaluated the efficacy and safety of canagliflozin versus placebo in preventing clinically important renal and cardiovascular outcomes in these patients. The trial enrolled approximately 4,400 patients in 34 countries.

Due to the global nature of CREDENCE and the critical importance of recruitment and retention to its success, it was extremely beneficial to have an experienced team of medical and scientific experts to oversee the trial globally from a top-tier level.

Aside from positioning the study on answering the fundamental scientific question aiming to address a key clinical need, George Clinical ensured that all scientific stakeholders remained engaged with the study and had clear roles, responsibilities and an accountability structure.

George Clinical was a natural fit to be selected to manage the academic-led steering committee and the broader scientific leadership team that provided oversight of CREDENCE. Our research scientists are leaders in the renal field with a track record of developing new strategies for the treatment and prevention of kidney disease across diverse populations. With over two decades of experience in renal research and multi-national collaboration, our teams are able to ensure effective study operations that are integrated with scientific focus, accelerate recruitment and ensure the most accurate outcomes possible. Their expertise in outcome studies includes the recent CANVAS and CANVAS-R trials exploring the same drug class. Their understanding of multi-national collaborations was a critical factor in making sure that despite language, cultural and clinical practice differences, all involved would be “speaking the same language” with regard to the key aspects of the trial.

CHALLENGES

Integration of scientific leadership with the operations of a large CRO across 690 sites in 34 countries posed significant challenges, from managing a large workforce to maintaining focus on the unified scientific purpose of the study and sustaining consistent and relevant communications. With so many stakeholders across multiple time zones, keeping everyone engaged in open dialogue was essential to understanding and adapting to the varying ways in which different countries manage kidney disease and define key endpoints. Limiting loss to follow up and withdrawal of consent are always a major concern in any clinical trial, but in a trial of such magnitude that is endpoint driven, it was critical to keep this ultimate loss of data to a minimum. With so much at stake and so many variables, it was extremely important to ensure that at trial’s end, there would be no questions as to the quality of the trial.