Overview of the rilparencel clinical program
ProKidney’s clinical development program is focused on patients with advanced CKD and diabetes who are at high risk of kidney failure. There are over 1 million people in the U.S. with Stage 3b/4 CKD and diabetes seeking better therapeutic options to prevent or delay the need for dialysis.
- Preclin
- IND
- Ph 1
- Ph 2
- Ph 3
- Approv
- Preclinical
- IND
- Phase 1
- Phase 2
- Phase 3
- Approval
REACT®/DKD
Diabetes Type II – Prevent/Delay CKD 3/4
(20-50 ml/min/1.73m2, N=81)
Fully Enrolled
Diabetes Type II – Prevent/Delay CKD 3/4
(20-50 ml/min/1.73m2, N=1,200)
Enrolling in US
Diabetes Type II –
Delay CKD 4/5
(14-20 ml/min/1.73m2, N=10)
Trial completed
Diabetes Repeat Dose Prevent/Delay CKD 3/4†
(20-50 ml/min/1.73m2, N=50‡)
enrollment completed
- Preclinical
- IND
- Phase 1
- Phase 2
- Phase 3
- Approval
REACT®/CAKUT
Congenital Anomalies – Prevent/Delay N=15
trial completed
Footnotes:
† injecting both kidneys w/ redose trigger
‡ Increased from 30 as indicated in Proxy Amendment No. 1, page 289
Preliminary Safety Profile
To date, rilparencel appears to be well tolerated in patients injected, and no adverse events related to rilparencel have been observed. The rilparencel safety profile will continue to be closely monitored in ongoing clinical trials.