Drugs / REACT
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05286853 | Jul → Sep 2024 | chronic kidney disease, type 2 diabetes mellitus | Prokidney | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-07-15 | Prokidney | Regulatory ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel prokidney.com ↗
FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetes |
| 2023-11-13 | Prokidney | Results ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates prokidney.com ↗
Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients |
| 2023-01-10 | Prokidney | Results ProKidney Announces Publication of Trial Design for Phase 2 Multicenter Clinical Trial of REACT for Late Stage 4 Diabetes-Related Chronic Kidney Disease prokidney.com ↗ |
| 2022-11-03 | Prokidney | Regulatory ProKidney Receives Allowance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for proact 1 (REGEN-006) and EMA Scientific Advice on Phase 3 Protocols of REACT for Diabetic Chronic Kidney Disease prokidney.com ↗
We are extremely pleased to announce that the MHRA has granted allowance to ProKidney to open sites in the UK, accepting the proact 1 study protocol that is already underway in the US and Canada. |
| 2022-06-23 | Prokidney | Results ProKidney Corroborates the Mechanism of Action of REACT™ with Cell Marker Analysis in Patients with Diabetic Chronic Kidney Disease prokidney.com ↗
The paper, published in Kidney International Reports, describes observed improvements in renal function and a wide array of clinical parameters in patients with moderate to advanced diabetic CKD treated with REACT™. |
| 2022-05-03 | Prokidney | Regulatory ProKidney highlights key registrational program elements supporting advancement of REACT® prokidney.com ↗
Furthermore, the FDA accepted ProKidney’s proposal for a long-term 5-year clinical follow-up program for all REACT® injected patients, to be enrolled with patients who have previously received REACT® injections in one or both kidneys. |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REACT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05286853 ↗ |
| Modality | Cell therapy | “Renal Autologous Cell Therapy (REACT)” NCT05286853 ↗ |