Neo-Kidney Augment (regenerative autologous cell therapy) / ProKidney - LARVOL DELTA

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Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Prokidney | N=600 ➔ 0 | Trial completion date: Apr 2028 ➔ Sep 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Apr 2028 ➔ Sep 2024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

Renal Autologous Cell Therapy (REACT) for Diabetic Chronic Kidney Disease: Phase II Trial with Bilateral Injections and Re-Dosing Triggers (NKF-SCM 2023) - "REACT and procedure related SAEs are expected to be commensurate with ongoing trials and SOC.Conclusion REACT cell-based therapies have the potential to effect nephron structure by preserving and stabilizing DKD progression and comorbidities. Current phase 2/3 trials are underway to determine efficacy, safety, renal function-dependent dosing, and time to treatment with bilateral kidney injections."

P2 data • Chronic Kidney Disease • Nephrology • Renal Disease • CST3

Novel Renal Autologous Cell Therapy (REACT) for Chronic Kidney Disease with Diabetes (DKD): Investigative Trial Experience in Mississippi (NKF-SCM 2023) - P2 | "The potential to delay time to kidney failure supported FDA and EMA regulatory allowance of two global phase 3 REACT trials.Conclusion Cell-based therapies have the potential to effect nephron structure and function by preserving, stabilizing, or improving DKD progression and comorbidities. Current phase 2/3 trials will determine efficacy, safety, renal dosing, and time to treatment with bilateral kidney injections."

Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

proact 1 and 2 Phase 3 Study Design: Randomized Controlled Studies of REACT in Participants with Type 2 Diabetes and Chronic Kidney Disease (NKF-SCM 2023) - "Standard-of-care therapies including RAASi , SGLT2i, and nsMRA should be given as per local guidance.Results Study Endpoints –Time-to-event primary composite endpoint taken from first injection to the earliest of >40% eGFR decline, eGFR < 15 mL/min/1.73m2 sustained for 30 days, initiation of chronic dialysis or kidney transplantation, or cardiovascular or renal death.Conclusion proact 1 and 2 are global phase 3 randomized controlled trials evaluating the safety and efficacy of REACT on major kidney disease endpoints, among pts with type 2 diabetes and moderate-severe CKD. REACT, a novel autologous cell therapy comprised of SRCs, has the potential to directly preserve 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 DIEASE: PHASE II TRIAL WITH BILATERAL CORTEX INJECTIONS AND RE-DOSING TRIGGERS (ISN-WCN 2023) - "Conclusions REACT™ 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 REACT™."

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

THE proact PHASE 3 STUDY DESIGN: A RANDOMIZED CONTROLLED STUDY OF REACT IN PARTICIPANTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ISN-WCN 2023) - "- 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

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: Jan 2028 ➔ Apr 2028 | Trial primary completion date: Jan 2028 ➔ Apr 2028

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