Xenotransplantation: A New Frontier in Kidney Transplantation, With Pranav Garimella, MBBS, MPH

Renal xenotransplantation has taken remarkable strides in 2025, transforming a long-theoretical concept into a tangible clinical reality with recent advances in genetically modified pig kidneys yielding improved compatibility, stronger early outcomes, and extended graft function.

These milestones, including the launch of the first US Food and Drug Administration (FDA)-approved clinical trials, signal a turning point that could reshape the future of kidney transplantation, potentially easing organ shortages and offering new hope to patients who cannot access a human donor kidney.

“Xenotransplantation is perhaps the most exciting frontier in kidney transplant that we've seen, and although it's not new, it's been around for a long time, this is the first time we've seen substantial improvements in patient outcomes and substantial longevity in these xenotransplanted kidneys,” Pranav Garimella, MBBS, MPH, Chief Medical Officer of the American Kidney Fund and an associate professor of medicine at UC San Diego, told HCPLive.

According to data from the Organ Procurement and Transplantation Network, more than 100,000 people in the US are currently on the national transplant waitlist, with another person added every 8 minutes. In 2023, more than 27,000 kidney transplants were performed, and nearly 90,000 people are still seeking a kidney transplant as of September 2024. With the number of patients seeking a transplant far exceeding the number of donor kidneys available, the US currently faces a major public health crisis.1

On February 3, 2025, the FDA made history when it cleared United Therapeutics’ Investigational New Drug application to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig, representing the first-ever clinical trial of a xenokidney.2

Most recently, the Agency cleared an Investigational New Drug application from eGenesis to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with end-stage kidney disease who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.3

On January 25, 2025, Tim Andrews, 67, received an EGEN-2784 kidney at Massachusetts General Hospital in the institution’s second successful transplant of a genetically edited pig kidney into a living recipient. He has now surpassed 7 months post-transplant, making him the world’s longest-living recipient of a genetically engineered porcine-derived organ.3

“I still think xenotransplantation is a bridge,” Garimella said, citing a current lack of knowledge about how long these kidneys will last and what risks might come with the use of these genetically modified organs. “I'm really hopeful. A lot of patients are unable to get kidneys from humans. They can't wait that long, and this would be a fantastic opportunity to get them off dialysis, which significantly impairs quality of life and their ability to do things that they would want.”

Editors’ note: Garimella has relevant disclosures with Otsuka and the PKD Foundation.

References

1. HRSA. Organ Donation Statistics. October 2024. Accessed September 11, 2025. https://www.organdonor.gov/learn/organ-donation-statistics

2. Brooks A. FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys. HCPLive. February 3, 2025. Accessed September 11, 2025. https://www.hcplive.com/view/fda-clears-first-xenotransplant-trial-gene-edited-kidneys

3. Brooks A. FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD. HCPLive. September 8, 2025. Accessed September 11, 2025. https://www.hcplive.com/view/fda-clears-ind-application-for-egen-2784-a-genetically-engineered-pig-kidney-for-eskd