About Us - ProKidney

Kidney Science Reimagined

ProKidney is redefining what’s possible in the treatment of chronic kidney disease. Leveraging deep scientific leadership in autologous cell therapy, we are advancing a first of its kind, personalized therapeutic approach designed to help preserve kidney function and delay the need for dialysis. As the only company developing an autologous cell therapy specifically for people with advanced chronic kidney disease (CKD), we are committed to filling a critical treatment gap for patients at the highest risk of kidney failure where their only options are dialysis or kidney transplant.

Protecting What Matters Most for Patients: Time and Quality of Life

Our work is grounded in compassion for the profound challenges of the kidney disease journey. We are driven by a clear purpose: to bring hope, stability, and meaningful change to patients and their families. Every step we take reflects our belief in the transformative potential of our breakthrough therapeutic platform.

ProKidney operates in lockstep with the devastating realities of the CKD patient burden that inspires its mission: to fulfill the potential of cell therapy to preserve kidney function, opening the door to an alternative treatment path that gives patients and families the promise of hope.

rilparencel Clinical Trials Are Underway

Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.

ProKidney is currently evaluating rilparencel in the Phase 3 REGEN-006 (PROACT 1) clinical trial for the treatment of patients with Stage 3b and 4 CKD and type 2 diabetes. This trial is being conducted at over 70 clinical sites in the United States, Asia, and Latin America. In addition, rilparencel has been studied in multiple Phase 2 clinical trials in patients with advanced CKD.

Previous trials indicate that rilparencel has a favorable safety profile.

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.