Recruitment Success in Large IgAN Trial Highlights Value of Scientific Leadership

SITUATION

As of early 2025, there were over 50 IgA Nephropathy (IgAN) clinical trials either recruiting or soon to be. The field is crowded and competitive. After decades of practically no innovation for this progressive disease (2021 KDIGO Guidelines acknowledged that no specific therapies for IgAN were available), things are suddenly moving forward very quickly. While that’s great news for patients — for researchers, it means a tough recruitment landscape.

Emerald Clinical has a strong history of meaningful participation in IgAN trials, and thanks to our successful collaboration in an ongoing Phase III IgAN study, the sponsor awarded us global Scientific Leadership of another large IgAN Phase III study with the goal of randomizing nearly 300 patients across the Americas, EMEA and APAC.

Our collaborative strength, reliable strategies and excellent recruitment / retention rates in the ongoing study gave our sponsor the confidence to partner again with our well-positioned team in their continuing efforts to give IgAN patients the world over hope for a better quality of life.

“We are listeners,” says Sergio Godoy, Associate Director of Scientific Services, “We let everyone know we’re going to listen to you. Everyone has a voice.”

SOLUTIONS

A robust and transparent communication network where all parties are represented, respected, informed, and motivated is the principal key to recruitment success.

With goals and timelines set, our scientific team of seven regional and 26 national leaders — nephrologists with expertise in IgAN therapy — got to work. Using their experience with the disease and their relationships with local sites, investigators and nephrologists, the team quickly identified the right sites and appropriate patients for the study. Once we met the sponsor’s revised goals due to the delay, we pressed forward to exceed their original goals / timelines, even though we were recruiting in the normally slow holiday season.

Through localized in-person investigator meetings and scientific webinars, sites and investigators were able to voice their questions, issues, successful strategies, and patient concerns. Giving everyone recognition and the ability to help shape study progression resulted in engaged and motivated teams and a cohesive, scientifically sound study. All stakeholders will be fully informed, represented and involved throughout the study.

Communication and specific knowledge of disease management allow our regional and national leaders to quickly intervene when any site reports patients who are considering dropping off the study. They can educate investigators on effective strategies for keeping those patients and advise on disease management if the patient is wanting to begin a recently offered therapy.

RESULTS

Recruitment has exceeded goals and expectations, which has shortened the enrollment window and moved the study forward more rapidly. When the sponsor sets a goal for a certain number of patients by a certain time, Emerald Clinical typically meets the goal earlier — even in typically slower periods such as holiday seasons. When sites have issues with patients who want to drop off for new medications coming available, our team steps in with recommendations and strategies.

Recruitment is ongoing, and new sites are being added. We are confident that with the perseverance of our collaborative, communicative network, this team will continue to meet or exceed all recruitment and retention goals in this important IgAN study. The goal of our sponsor to get innovative treatments to as many IgAN patients as possible, as quickly as possible, matches that of Emerald Clinical — a better quality of life leaving no patient behind.