Recent Updates
Recently added Catalysts

Renal Autologous Cell Therapy

Phase 3

Type 2 Diabetes Mellitus | Monoclonal antibody | Metabolic |ProKidney Corp.|Last Updated: Mar 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment778
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05099770Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney DiseasePHASE3 RECRUITING 685 — — Jan 5, 2022Dec 1, 2029Mar 23, 202695 United States, Australia +5
NCT03270956A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney DiseasePHASE2 COMPLETED 10 — — Apr 25, 2018Nov 17, 2022Mar 24, 20254 United States
NCT02836574A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney DiseasePHASE2 COMPLETED 83 — — Sep 1, 2016Dec 1, 2023Aug 24, 202516 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
18 months after the 135th participant receives their first injection / sham.

The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.

Clinical Endpoint
From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

The time from first injection to the earliest of: * At least 40% reduction in eGFR, sustained for 30 days, OR * eGFR \<15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR * Renal or cardiovascular death

Procedure and/or Product Related Adverse Events
Through 24 months following last REACT injection

Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term

Change in Renal Function
Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm

Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.

Secondary Endpoints
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
Secondary Endpoint: All-cause mortality.
From date of first injection to all-cause mortality assessed up to 94 months.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sham ProcedureSHAM_COMPARATORParticipants randomized to the Sham Comparator arm will have 2 sham procedures.
Experimental (REACT/rilparencel injections)EXPERIMENTALParticipants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
Renal Autologous Cell Therapy (REACT)EXPERIMENTALRenal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Active TreatmentEXPERIMENTALRenal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Deferred TreatmentACTIVE_COMPARATORRenal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
Interventions
NameTypeDescription
Renal Autologous Cell Therapy (REACT/ rilparencel)BIOLOGICALParticipants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.
Sham ComparatorPROCEDUREParticipants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.
Renal Autologous Cell Therapy (REACT)BIOLOGICALAutologous selected renal cells (SRC)
Renal BiopsyPROCEDUREa procedure in which a small sample of kidney tissue is removed
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites95

Key Inclusion Criteria: 1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease 3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening. 4. Systolic blood pressu...

Countries:United StatesAustraliaCanadaMexicoPuerto RicoTaiwanUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05099770primaryCompletionDate: changed
LOWMay 24, 2026NCT05099770studyFirstPostDate: changed