Clinical Studies

ProKidney has developed an investigational cell-based product called rilparencel designed to preserve kidney function by stabilizing estimated glomerular filtration rate (eGFR) or attenuating the rate of eGFR decline in patients with CKD.

Rilparencel is being developed 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.

To date, clinical studies suggest that treatment with rilparencel in patients with CKD caused by type 2 diabetes may positively impact renal function by stabilizing eGFR or attenuating the rate of eGFR decline.

Over 36-37 million patients are currently living from Chronic Kidney Disease (CKD)

Type 2 diabetes is the leading cause of CKD in the United States accounting for approximately 44% of new CKD patients, and therapeutic options to slow the progression of CKD are limited. ProKidney is currently conducting multiple clinical trials with rilparencel in patients with CKD. Previous trials suggest that rilparencel is well tolerated by patients with moderate-to-severe CKD and based on early clinical efficacy signals is now under investigation in Phase 3 studies.

Our Product Candidate

Rilparencel is currently in a Phase 3 development program for the treatment of patients with Stage 3b and Stage 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 conducted in the United States.

The ongoing clinical development program utilizes a newly developed percutaneous kidney injection method, tested in phase 2 studies,  that is conducted using conscious sedation in an outpatient same-day procedure. The safety profile of the rilparencel treatment procedure is similar to that of a routine kidney biopsy.

Our Approach

ProKidney’s dedicated team of cell therapy scientists and engineers has developed production methods to meet the requirements of the clinical programs. A product-specific analytical testing program has been designed, and assays have been qualified, to ensure product quality is prioritized. Process development strategies are implemented to gain efficiency while maintaining safety and quality profiles.

Process Development

Process development is a highly complex task requiring custom-developed solutions for cell-based products. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and quality control. The collective experience gained over a decade provides us with deep process development and analytical knowledge, enabling the implementation of robust manufacturing solutions that we utilize in developing our products.