George Clinical Exceeds Recruitment and Retention Goals in Important Global IgA Nephropathy Study

At the peak of the COVID pandemic, recruitment was met, and patient visits continued safely.

SITUATION

IgA Nephropathy (IgAN) is a disease with a relative lack of progress in innovation and a population largely absent from research data until recently. It’s a disease that behaves differently in different populations. For example, in people of East and Southeast Asian origin, IgAN is more common and more likely to lead to dialysis. This highlights the need for globally diverse and inclusive clinical research across all populations to gain an understanding of how drugs work in people with different genetic backgrounds from different parts of the world.

George Clinical was called upon to handle the Asia-Pacific operations of a global Phase II double-blind randomized trial for a treatment to decrease proteinuria in IgAN patients. Working alongside a global CRO, George Clinical was responsible for project management, site management/monitoring, regulatory services, safety reporting and add-on Scientific Leadership.

With a reputation as the leading kidney and metabolic CRO and a broad resume of landmark studies, George Clinical was an excellent collaborator to help ensure the success of this milestone trial.

A strength of this trial was the racial and demographic composition, which was consistent with the known distribution of IgAN and supported the generalizability of the results—reflecting the higher prevalence and more rapid progression of IgAN in Asian populations

CHALLENGES

George Clinical realized early on that this study would greatly benefit from our Scientific Leadership services, which were not originally contracted. Due to the rare nature of the disease and the difficulty in recruiting patients for trials, we recommended our Scientific Leadership expertise be part of the study.

Recruitment was also challenged as it began at the height of the pandemic when everything was suddenly shut down and travel became difficult for patients and staff alike. Safety of all operational teams and patients became a primary concern for keeping the study on track.