ProKidney Corporation announced that the FDA has confirmed eGFR slope as an acceptable surrogate endpoint for the accelerated approval of rilparencel, its autologous cell therapy for chronic kidney disease (CKD) and type 2 diabetes. The ongoing Phase 3 PROACT 1 study will serve as the basis for both accelerated and full approval, with topline data for accelerated approval expected in Q2 2027. Nearly half of the necessary patients for the accelerated approval analysis are currently enrolled.
This FDA alignment is crucial for ProKidney as it de-risks the development pathway for rilparencel, offering a faster route to market. It signifies a potential breakthrough for patients with CKD and type 2 diabetes, a population with limited effective treatment options and currently facing a high risk of progression to dialysis or kidney transplant. The accelerated approval pathway, based on eGFR slope, allows ProKidney to potentially bring rilparencel to patients sooner, offering a much-needed therapy that aims to preserve kidney function. This could significantly improve patient outcomes and reduce the burden of this debilitating disease.
The FDA agreed that an effect size of at least 1.5 mL/min/1.73m²/year improvement in eGFR slope would be an acceptable efficacy demonstration. The Phase 3 PROACT 1 study, which includes approximately 685 participants with Stage 3b/4 CKD and type 2 diabetes, will assess the efficacy of rilparencel delivered via a minimally invasive procedure. The primary composite endpoint for full approval is a combination of factors related to kidney function decline, dialysis, transplant, or renal/cardiovascular death.
This regulatory clarity enables ProKidney to focus on completing patient enrollment and achieving positive results in the PROACT 1 study. The potential accelerated approval of rilparencel could significantly impact the CKD treatment landscape, offering a new therapeutic option for patients and establishing ProKidney as a leader in the field of cellular therapies for kidney disease. This positive development sets the stage for potential future growth and investment in this critical area of unmet medical need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
