Q&A with Bruce Culleton, MD, Chief Executive Officer, ProKidney, Inc.
Tell us about your first experience with a kidney patient, personally or professionally, and what impressions that left on you as a fellow human being?
My earliest recollection is an experience during my Internal Medicine training 30 years ago. I admitted a young woman into the hospital with known kidney disease due to Lupus. She rapidly progressed to kidney failure. Despite receiving the aggressive treatment available at that time, she passed away, leaving behind a young child and husband. Her death deeply affected me and left me with several questions related to her care prior to hospital admittance. Could we have done something better? Did we miss anything? Why don’t we have better treatment for patients with rapidly progressive kidney disease?
Can you tell our AAKP national and global audiences why/how ProKidney first came into the kidney disease space and about the company’s commitment to kidney patients and their families?
ProKidney was founded on the mission to preserve kidney function, opening the door to an alternative treatment path (beyond dialysis or kidney transplant) and became a public company in 2022 after more than 15 years of pre-clinical and early phase clinical studies. We are advancing a breakthrough cell therapy, rilparencel, that is being tested in a Phase 3 study to preserve kidney function and potentially delay the need for dialysis in patients with advanced CKD. For patients and their families, delaying dialysis could mean preserving normalcy, independence, and the ability to be present for life’s most important moments. Our purpose is centered around and fueled by patients, which is why we have a Patient Advisory Board that ffers unique insights and real lived experiences that better help us serve the patient community. These individuals guide us on aspects that are not always captured by clinical data, help shape our study protocols, and patient-facing educational materials. To ground our work in the real-life impact of kidney disease, we invite patients to our company events to share their stories and lived experiences – they are truly the center of everything we do.
We also partner with patient advocacy organizations like AAKP to increase awareness about kidney disease, clinical trials and treatments.
As we know, preserving native kidney function for those with diabetes and CKD is of the utmost importance. Tell us about ProKidney’s cell ther-apy candidate, rilparencel, which, according to early clinical data, has the potential to preserve kidney function and potentially delay or elimi-nate the need for dialysis.
Rilparencel is a minimally invasive injectable prod-uct formulated from the patient’s own (autologous) kidney cells (obtained by a kidney biopsy) and injected back into the patient’s kidneys. The full results from our Phase 2 REGEN-007 trial suggest that rilparencel has the potential to preserve kidney function and potentially delay or eliminate the need for dialysis. In one cohort of the study, treatment with rilparencel was associated with a 78% im-provement in the decline of kidney function.
The cells formulated in rilparencel are believed to utilize innate kidney restorative mechanisms that remain active in a chronically diseased kidney, thereby preserving kidney function. As a personal-ized (autologous) cell therapy, rilparencel may ease the treatment burden for CKD patients: requiring no pre-treatment therapy (as other cell/gene therapies often do); no daily or weekly medications or injec-tions; and no immunosuppressive therapy to prevent rejection.
We understand that rilparencel is a cell-based product that is currently in Phase 3 of clinical study for the treatment of patients with Stage 3b and 4 CKD and type 2 diabetes. How can pa-tients learn more about this study and follow its progress?
Patients and their care partners can learn more about the study and how to participate by going to www.HopeforCKD.com. We will provide updates on our progress at scientific meetings and company press releases at our corporate website https://prokidney.com/.
Innovation in the kidney space is important to patients. They want to be involved and have their voice heard. Can you express the importance of why patients, in consultation with the healthcare professionals they choose to care for them, should have access to and choose what treatment, whether established or new innovation, is right for them?
People living with kidney disease are experts in their own lived experience, and their perspectives should play a meaningful role in their treatment journey. In partnership with the healthcare professionals they trust, patients should have access to treatment options spanning established therapies and emerging innovations through clinical trials, so care decisions can be tailored to individual clinical needs, lifestyle considerations, and personal goals.
As a leader in healthcare, you know well that it is not easy to develop a novel approach to treat or enhance care. What do you draw upon internally to keep your drive, optimism, and focus on patients going at full speed during the tough days?
I have worked in the kidney space in a variety of roles for nearly 30 years and throughout that time, my motivation has been grounded in a goal to make a meaningful difference in the lives of patients with CKD and the people who love them. On the toughest days, I draw renewed energy by thinking about patients I’ve cared for, or I know through my work, or by reading their personal stories in the news or social media. They are a reminder of both the urgency for innovation and the responsibility we carry as healthcare leaders. I am deeply fortunate to have found a calling so closely aligned with a meaningful purpose.
Final question – AAKP patients think this last question reveals a lot about a person – who is one of your heroes and why?
I honestly don’t have a hero in the traditional sense. I am most inspired by everyday people who quietly make a difference in other people’s lives. Many times, they are not even aware of the impact they are having. They could be patients, physicians, researchers, care partners, family and friends. You know it when you see them and it is so inspiring. The best example I have is a nephrologist who I worked with early in my career. He was a great example for all junior nephrologists and students interested in research. I did not know until after he retired that he donated a kidney some time ago. He didn’t make a big deal about this. I guess I wasn’t surprised knowing who he was. When I found out, I smiled and felt good about our world.
Dr. Bruce Culleton is a nephrologist who joined ProKidney as CEO in 2023. He brings nearly three decades of deep expertise in the kidney space, where he has held roles including: clinical nephrologist caring for patients, medical director for a CKD clinic and home dialysis program, global renal therapeutic area lead at Baxter Healthcare, and Chief Medical Officer for CVS Kidney Care. Today, he leads a team of approximately 250 passionate, purpose-driven employees at ProKidney, guiding the organization’s mission to transform kidney health.
