Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Renal Autologous Cell Therapy · 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...
Renal Autologous Cell Therapy (REACT, rilparencel) is an investigational cell therapy being studied for chronic kidney disease, including chronic kidney disease associated with type 2 diabetes mellitus and congenital anomalies of the kidney and urinary tract. It is being developed by ProKidney Corp. (PROK) and is currently in clinical development.
Renal Autologous Cell Therapy (REACT, rilparencel) is a renal autologous cell therapy, meaning it uses a patient's own kidney cells. The therapy is designed to address chronic kidney disease by potentially restoring kidney function. Its specific molecular target has not been disclosed.
Renal Autologous Cell Therapy (REACT, rilparencel) is being developed by ProKidney Corp., a biopharmaceutical company traded on the stock exchange under the ticker PROK. ProKidney is focused on developing cell therapies for chronic kidney disease.
Renal Autologous Cell Therapy (REACT, rilparencel) is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial, called PROACT, is active but not recruiting participants.
Renal Autologous Cell Therapy (REACT, rilparencel) has been studied in several clinical trials. These include NCT02836574, a Phase 2 study in type 2 diabetics with chronic kidney disease; NCT04115345, a Phase 1 study in patients with chronic kidney disease from congenital anomalies; NCT05018416, a Phase 2 study in type 1 or 2 diabetes and chronic kidney disease; and NCT05099770, a Phase 3 study in type 2 diabetes and chronic kidney disease.
Yes, Renal Autologous Cell Therapy is also known as REACT and rilparencel. These names refer to the same investigational cell therapy being developed by ProKidney Corp. for chronic kidney disease.