About Us

We are a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate that aims to transform the therapeutic landscape in Chronic Kidney Disease (CKD).

Over 35 million U.S adults have CKD with approximately 135,000 patients progressing to dialysis every year. Therapeutic options to delay the need for dialysis in patients with Stage 4 CKD are limited. While current treatments can slow the progression of CKD to End Stage Kidney Disease (ESKD), there is no cure for CKD. ProKidney is at the forefront in the field of cellular therapy focused on preserving kidney function and potentially delaying or eliminating the need for dialysis.
Our lead product candidate, rilparencel, aims to disrupt the CKD therapeutic landscape and improve quality of life for patients and their families. Early clinical data suggest that rilparencel has the potential to preserve kidney function and potentially delay or eliminate the need for dialysis. Rilparencel is a percutaneous minimally invasive injectable product prepared from the patient’s own kidney cells. Because rilparencel is prepared from the patient’s own cells, a lifetime of immunosuppressive therapy to prevent rejection is not required.

rilparencel Clinical Trials Are Underway

Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. ProKidney is currently conducting clinical trials with rilparencel in a Phase 3 development program for the treatment of patients with Stage 3b and 4 CKD caused by type 2 diabetes. These trials are planned to be conducted at approximately 150 clinical sites in the United States, Europe, Asia, Latin America and Australia. In addition, rilparencel has ongoing Phase 2 clinical trials in patients with Stage 3 and Stage 4 CKD.

Previous trials indicate that rilparencel is well tolerated by patients with moderate-to-severe CKD.

We are initially pursuing the development of REACT for use in moderate to severe CKD patients in the United States and selected countries around the world with diabetes as the primary cause. We estimate that approximately 38-39 million adults, representing approximately 15% of the U.S. adult population, currently suffer from CKD, of which approximately 17-18 million patients have stage 3 or 4 CKD, and approximately 13.4 million patients have stage 3 or 4 CKD that is caused by diabetes (approximately 8.3 million) or hypertension (approximately 5.1 million). With respect to those patients with CKD caused primarily by diabetes, we estimate that approximately 4-5 million patients would be eligible to be treated with REACT, should it be approved by the FDA for commercial use in the U.S.