Arbor Research Collaborative for Health is excited to announce a partnership with CSL Vifor to launch a multinational registry designed to capture real-world outcomes of difelikefalin (Kapruvia®), a newly-approved treatment for chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis (HD) patients. Known as PARADIGM (PAn european Registry Addressing pruritus in DIalysis with a focus on Goal oriented Medical treatment), the registry will include several hundred initiators of Kapruvia® across five European countries (France, Germany, Italy, Spain, UK), with patient enrollment set to begin in Q1 2025, and follow-up continuing through 2028.

With over 25 years of experience administering the Dialysis Outcome and Practice Patterns Study (DOPPS), a prospective cohort study of HD patients across more than 20 countries and including over 100 European HD facilities, Arbor Research is well-positioned to design and implement this registry of Kapruvia® initiators, in close collaboration with local investigators and clinics in participating countries. A steering committee with national leaders will be formed and the first patients are expected to be recruited in 2025. Arbor Research / DOPPS investigators have led several studies demonstrating strong and consistent associations between itch severity and a variety of clinical and patient-reported outcomes (PROs). With a novel and effective therapy now available in Europe, PARADIGM will improve the understanding of several aspects of real-world Kapruvia® utilization, and offer insights to better inform providers, physicians, and patients.

“Treatment registries are crucial to investigate a number of aspects of medication utilization and effectiveness that are not possible in a randomized clinical trial (RCT) setting,” said Christopher Spera, PhD, President and CEO of Arbor Research. “Understanding how medications like Kapruvia® perform in the real-world across diverse healthcare systems can help optimize strategies to improve patient outcomes and help shape treatment guidelines.”

Key objectives of PARADIGM include: (1) describing the profiles of Kapruvia®  initiators, including CKD-aP treatment history and itch severity; (2) understanding trajectories of DFK dosing patterns, start/stop, concomitant therapies, and reasons for change in prescription; (3) effectiveness through assessing PROs including itch severity, sleep quality, and depression; (4) safety, by monitoring tolerability and adverse events; and (5) Healthcare Resource Utilization (HCRU), including emergency department visits, hospitalizations, and referrals to specialists.

“By collecting robust multi-national real-world data, we aim to enhance our understanding of Kapruvia®’s role in managing CKD-aP symptoms and improving patient quality of life,” said Angelo Karaboyas, PhD, Senior Research Scientist and Principal Investigator for PARADIGM at Arbor Research.

Data from the PARADIGM registry can play an important role in advancing medical knowledge, and can provide supporting evidence for treatment guidelines, with the goal of ultimately helping clinicians better manage CKD-aP symptoms for patients on dialysis who suffer from itch.