Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Renal Autologous Cell Therapy, Renal Autologous Cell Therapy (REACT)
Rilparencel · 5 trials · 5 indications
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.
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
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
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.
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.
| Arm | Type | Description |
|---|---|---|
| Sham Procedure | SHAM_COMPARATOR | Participants randomized to the Sham Comparator arm will have 2 sham procedures. |
| Experimental (REACT/rilparencel injections) | EXPERIMENTAL | Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel. |
| 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections | EXPERIMENTAL | Cohort 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 Injection | EXPERIMENTAL | Cohort 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) | EXPERIMENTAL | Renal 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 Treatment | EXPERIMENTAL | Renal 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 Treatment | ACTIVE_COMPARATOR | Renal 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. |
| Name | Type | Description |
|---|---|---|
| Renal Autologous Cell Therapy (REACT/ rilparencel) | BIOLOGICAL | Participants 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 Comparator | PROCEDURE | Participants 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) | BIOLOGICAL | Autologous selected renal cells (SRC) |
| Renal Biopsy | PROCEDURE | a procedure in which a small sample of kidney tissue is removed |
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...
Rilparencel is an investigational autologous cell therapy being developed by ProKidney Corp. for chronic kidney disease, including patients with type 2 diabetes mellitus. It is also known as Renal Autologous Cell Therapy, or REACT. It is not yet approved and remains in clinical development.
Rilparencel is being studied for chronic kidney disease, including diabetic kidney disease in patients with type 2 diabetes mellitus. Trial populations have also included type 1 diabetes and chronic kidney disease from congenital anomalies of the kidney and urinary tract. It is investigational and has not been approved for any indication.
Rilparencel is developed by ProKidney Corp., which trades under the ticker PROK. The company sponsors the clinical program, including the Phase 3 Proact study and earlier Phase 1 and Phase 2 studies of the therapy in chronic kidney disease.
Rilparencel is in Phase 2 development overall, with a Phase 3 trial also under way. The Phase 3 Proact study in type 2 diabetes and chronic kidney disease is active and not recruiting. Two completed Phase 2 studies and one completed Phase 1 study support the program.
Rilparencel has been studied in four trials. NCT05099770 is the active Phase 3 Proact study in type 2 diabetes and chronic kidney disease. Completed studies include NCT05018416 (REGEN-007, Phase 2), NCT04115345 (Phase 1 in CKD from congenital anomalies), and NCT03270956 (Phase 2 in diabetic CKD).
Yes. Rilparencel is also known as Renal Autologous Cell Therapy, abbreviated REACT. The names refer to the same investigational cell therapy developed by ProKidney Corp. for chronic kidney disease, so searches for REACT and for rilparencel point to the same program.