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Clinical trials
catalyst calendar across sponsors →Studies where PROK is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
8 interventional · 2 observational · 2 with posted results
Held by 6 tracked-famous managers (RENAISSANCE TECHNOLOGIES LLC, MILLENNIUM MANAGEMENT LLC, TWO SIGMA INVESTMENTS, LP, SUSQUEHANNA INTERNATIONAL GROUP, LLP, Squarepoint Ops LLC, +1 more) · FINRA short interest 22.4 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen ProductNCT06790498observationalLong-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. | — | Enrolling by invitation | Biological: Renal Autologous Cell Therapy (REACT) | Diabetic Kidney Disease, Chronic Kidney Disease | 50 | 2030-05-31 | in 1,381 d | 2025-01-24 |
| Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney DiseaseNCT05099770Surrogate / Intermediate Efficacy Endpoint -eGFR SlopeRandomized · Triple-masked · Treatment | Phase 3 | Active, not recruiting | Biological: Renal Autologous Cell Therapy (REACT/ rilparencel) · Procedure: Sham Comparator | Type 2 Diabetes Mellitus, Chronic Kidney Diseases | 685 | Dec 2029 | ≤ 1,230 d | 2026-08-11 |
| A Long-Term Follow-Up Study of Participants Exposed to REACTNCT05918523observationalPrimary Endpoint: Long-term safety of REACT | — | Recruiting | Biological: Renal Autologous Cell Therapy (REACT) | Diabetic Kidney Disease, Chronic Kidney Diseases | 80 | Jan 2028 | ≤ 530 d | 2025-05-28 |
| Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)NCT05018416Improvement 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 equationRandomized · Open-label · Treatment | Phase 2 | Completed | Biological: Renal Autologous Cell Therapy (REACT) | Chronic Kidney Diseases, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus | 53 | 2025-05-20actual | — | 2026-03-13 |
| A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney DiseaseNCT05286853Primary Composite EndpointRandomized · Double-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration. | Biological: Renal Autologous Cell Therapy (REACT) · Procedure: Sham Comparator | Type 2 Diabetes Mellitus, Chronic Kidney Diseases | 0 | 2024-09-03actual | — | 2024-09-25 |
| A Study of Participants With Chronic Kidney Disease Previously Treated With REACTNCT05694169Primary Endpoints is as follows:Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: business decision | Biological: Renal Autologous Cell Therapy (REACT) | Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases | 1 | 2024-03-19actual | — | 2025-02-28 |
| A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney DiseaseNCT02836574Change in Renal FunctionRandomized · Open-label · Treatment | Phase 2 | Completed | Biological: Renal Autologous Cell Therapy (REACT) · Procedure: Renal Biopsy | Type 2 Diabetes Mellitus, Chronic Kidney Disease | 83 | Dec 2023actual | — | 2025-08-24 |
| A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).NCT04115345Assess 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].Open-label · Treatment | Phase 1 | Completed | Biological: Renal Autologous Cell Therapy (REACT) | Chronic Kidney Disease, Congenital Anomalies of Kidney and Urinary Tract | 6 | 2023-01-31actual | — | 2023-12-21 |
| A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney DiseaseNCT03270956results2025-03-24Procedure and/or Product Related Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Renal Autologous Cell Therapy (REACT) | Type 2 Diabetes Mellitus, Chronic Kidney Disease | 10 | 2022-11-17actual | — | 2025-03-24 |
| Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)NCT02525263results2021-04-23Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA ImplantationOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The single patient enrolled began hemodialysis treatments. | Biological: Neo-Kidney Augment | Chronic Kidney Disease, Type 2 Diabetes | 1 | May 2017actual | — | 2021-04-23 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19