Neo-Kidney Augment (rilparencel) / ProKidney - LARVOL DELTA

Using a Human Decedent Model to Elucidate the Mechanism of Action of Rilparencel, an Investigative Autologous Renal Cell Therapy for the Treatment of CKD (KIDNEY WEEK 2025) - P3 | "The association of molecular findings with functional clinical outcomes will be assessed throughout the study. Conclusion Detailed characterization of rilparencel’s MoA using advanced multi-omic analyses in a decedent model could significantly enhance our understanding of autologous renal cell therapies in CKD treatment."

Chronic Kidney Disease • Nephrology • Renal Disease

Expanded Protein and Metabolic Secretome Characterization of Renal Cell Therapy Candidate Rilparencel (KIDNEY WEEK 2025) - "Conclusion Secretome characterization during rilparencel manufacturing exhibits a tissue remodeling and/or wound healing profile. Key secretome markers and metabolites may be useful in further enriching product characterization."

Chronic Kidney Disease • Inflammation • Renal Disease

Renal Autologous Cell Therapy in Diabetes and CKD (KIDNEY WEEK 2025) - P2 | "Conclusion Bilateral kidney INJ of rilparencel preserves kidney function with an acceptable safety profile. A phase 3, randomized, sham-controlled study is ongoing."

Late-breaking abstract • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders

Cell-Specific Inflammatory Profile Characterization of the Cell Therapy Candidate Rilparencel (KIDNEY WEEK 2025) - "Pathway analysis suggests involvement of several potential immune modulatory pathways and supports further evaluation of cell state. Conclusion Specific cell type/state assessments performed during the manufacturing of rilparencel indicates a reduced inflammatory profile and provides enhanced product characterization knowledge."

Chronic Kidney Disease • Renal Disease

ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel (GlobeNewswire) - "ProKidney Corp...announced confirmation of alignment with the U.S. Food and Drug Administration (FDA) on the accelerated approval pathway for rilparencel...In a recent Type B meeting, the FDA confirmed that the slope of estimated glomerular filtration rate (eGFR) in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission of rilparencel under the accelerated approval pathway. The FDA agreed that a rilparencel effect size (versus sham controls) of at least 1.5 mL/min/1.73m2/year improvement would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. ProKidney anticipates topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in Q2 2027...Updated guidance on the expected timing of the confirmatory readout will be provided in 1H 2026."

FDA event • P3 data: top line • Chronic Kidney Disease

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007) (clinicaltrials.gov) - P2 | N=53 | Completed | Sponsor: Prokidney | Active, not recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ May 2025 | Trial primary completion date: Jun 2026 ➔ May 2025

Trial completion • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Study of Participants With Chronic Kidney Disease Previously Treated With REACT (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: Prokidney | N=10 ➔ 1 | Trial completion date: Jun 2025 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Mar 2024; business decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Kidney Disease • Nephrology • Renal Disease

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product (clinicaltrials.gov) - P=N/A | N=50 | Enrolling by invitation | Sponsor: Prokidney

New trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Prokidney | N=600 ➔ 0 | Trial completion date: Apr 2028 ➔ Sep 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Apr 2028 ➔ Sep 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Prokidney | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

REGEN-006: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=685 | Recruiting | Sponsor: Prokidney | Active, not recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

REGEN-006: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Prokidney | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Rilparencel (Renal Autologous Cell Therapy-REACT®) for Chronic Kidney Disease and Type 1 and 2 Diabetes: Phase 2 Trial Design Evaluating Bilateral Kidney Dosing and Re-Dosing Triggers. (PubMed, Am J Nephrol) - "This multicenter phase 2 RCT is designed to investigate the efficacy and safety of rilparencel with bilateral kidney dosing and comparing two injection schedules with the potential of preserving or improving kidney function and delaying kidney disease progression among patients with Stages 3a-4 CKD with diabetes."

Journal • P2 data • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease

A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=83 | Completed | Sponsor: Prokidney | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Prokidney | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007) (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: Prokidney | Trial completion date: May 2025 ➔ Sep 2026 | Trial primary completion date: May 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Prokidney

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Prokidney

Trial completion date • Trial initiation date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Renal Autologous Cell Therapy (REACT) to Delay Dialysis in Advanced CKD (KIDNEY WEEK 2023) - P2 | "REACT was tolerated and preserved function to decelerate eGFR decline, suggesting a non-dialytic treatment option for T2DKD progressing to RRT. Phase 3 randomized controlled trials and safety monitoring are underway."

Metastases • Anemia • Diabetes • Fatigue • Hematological Disorders • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Pain • Pneumonia • Renal Disease • Respiratory Diseases • Type 2 Diabetes Mellitus

A Study of Participants With Chronic Kidney Disease Previously Treated With REACT (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Prokidney | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Prokidney

New trial • Chronic Kidney Disease • Nephrology • Renal Disease

THE PROACT 2 PHASE 3 STUDY DESIGN: A RANDOMIZED CONTROLLED STUDY OF REACT IN PARTICIPANTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ERA-EDTA 2023) - "proact 2 is a global Phase 3 randomized controlled trial that will evaluate the safety and efficacy of REACT on major kidney disease endpoints, among participants with type 2 diabetes and moderate-severe CKD. This trial is part of a comprehensive phase 3 development program with an estimated start date of June 2023. REACT, a novel autologous cell therapy composed of SRC, has the potential to directly improve kidney function with a goal to prevent kidney failure."

Clinical • P3 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Transplantation • Type 2 Diabetes Mellitus

RENAL AUTOLOGOUS CELL THERAPY (REACT™) FOR DIABETIC CHRONIC KIDNEY DISEASE: PHASE II TRIAL WITH BILATERAL CORTEX INJECTIONS AND RE-DOSING TRIGGERS (ERA-EDTA 2023) - "REACTTM cell-based therapy has the potential to effect nephron structure and function by stabilizing or improving DKD progression and its comorbidities. Current phase II and III trials are underway to determine efficacy, safety, renal function-dependent dosing, and time to treatment with bilateral kidney injections of REACTTM."

P2 data • Anesthesia • Chronic Kidney Disease • Diabetic Nephropathy • Nephrology • Renal Disease • CST3

A Study of Participants With Chronic Kidney Disease Previously Treated With REACT (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Prokidney | Initiation date: Apr 2023 ➔ Jul 2023

Trial initiation date • Chronic Kidney Disease • Nephrology • Renal Disease

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007) (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: Prokidney | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus