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Renal Autologous Cell Therapy

Phase 3

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

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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment778
FDA Designations
No designations recorded
Clinical trial landscape

Renal Autologous Cell Therapy · 5 trials · 5 indications

Phase 3 1Phase 2 3Phase 1 1
NCT05099770Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney DiseaseType 2 Diabetes Mellitus
RECRUITING685 Analytics
PHASE3RECRUITING
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Type 2 Diabetes Mellitus
NCT05099770685
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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

Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
Screening thru month 28
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
Screening thru 18 months after the last injection of study drug
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.

Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety].
18 months following last REACT injection

The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 18 months post-treatment.

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.
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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.
2 Renal Autologous Cell Therapy (REACT)/ rilparencel injectionsEXPERIMENTALCohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
1 Renal Autologous Cell Therapy (REACT)/ rilparencel InjectionEXPERIMENTALCohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney.
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
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Eligibility Criteria
Age Range30 Years to 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
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05099770primaryCompletionDate: changed
LOWMay 24, 2026NCT05099770studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT05018416TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT05018416TRIAL_REMOVED: changed