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Promising results in the effort to eliminate the need for immunosuppressant medicines for transplant recipients

Researchers testing a new therapy to prevent organ rejection without using immunosuppressants recently published promising results
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For many people living with kidney failure, a kidney transplant offers a new beginning and greatly improves quality of life. While it is not a cure, a transplant is a highly effective treatment that allows many people living with kidney failure to return to work or school and to activities they enjoy with increased energy and freedom from the physical, mental and logistical tolls of dialysis. In short, a kidney transplant can help recipients feel more like themselves again. 

If you are living with a kidney transplant, you will need to take immunosuppressant medicines to keep your new kidney healthy. These medicines work by calming your immune system, which normally protects you by attacking things it sees as "intruders," like viruses and bacteria. In certain conditions — such as lupus, vasculitis or Crohn's disease — immunosuppressants can also help by preventing the immune system from mistakenly attacking healthy cells. After a transplant, your immune system naturally recognizes the donated kidney as something new or foreign. Immunosuppressants ensure your body accepts the organ, protecting it from rejection and helping your transplant succeed.

Unfortunately, immunosuppressants come with new challenges to navigate, including side effects, strict adherence to your medication schedule, cost and access. The available immunosuppressant options have also been limited. There has not been a new immunosuppressant medication approved by the Food and Drug Administration (FDA) since 2012. This means that if you have side effects to the immunosuppressants, you may have limited options of alternative medicines to try to see if you react better to it — like you often can with other types of medicines.  

But there is hope on the horizon for transplant recipients.

Researchers testing a new therapy to prevent organ rejection without using immunosuppressants recently published promising results in the American Journal of Transplantation. In a clinical trial with participants from multiple hospitals, the study tested whether people who received a kidney transplant and received a stem cell transplant at the same time could stop using immunosuppressants after a year. 

In an interview with Mayo Clinic, Dr. Mark Stegall, the lead clinical investigator for the study and a transplant researcher at Mayo, explained the process.

"The donor not only donates a kidney, but they're donating part of their bone marrow cells," Stegall said. "[When the donor comes in] they're given a medicine to mobilize those cells out of their bone marrow and into their bloodstream, and then they're collected via the vein. We collect those and those can go and be frozen down and processed and that… bone marrow is part of the transplant."

The findings were encouraging. Of the 20 participants, 19 were able to stop using immunosuppressant medicines after one year. Additionally, 15 (75%) trial participants were able to stop taking medicine for more than two years. 

All participants received their transplants (kidney and stem cell) from a sibling whose tissue types closely matched theirs. Participants received their kidney transplants, underwent radiation and then received the stem cell transplant. 

In an interview with MedPage Today, Dr. Stegall said that next steps for the study "are to win FDA approval and become standard of care and then try to determine whether the strategy can be applied to a broader audience of less well-matched recipients." He added that at this time, the strategy requires a living donor so its use would be limited to kidney transplants and possibly partial liver or lung transplants. 

Side effects, which can vary among patients, represent one of the hardest parts of taking immunosuppressants. 

According to a survey of over 10,000 patients published in July 2025 by the American Society of Transplantation (AST), 92% of patients had experienced at least one side effect from their immunosuppressant medicine. The most common side effects were fatigue, headaches, insomnia, tremors and mood but others include diarrhea, vomiting, weight gain and hair loss. Immunosuppressants also weaken your entire immune system, putting you at an increased risk for infections and sickness and for developing health conditions like gout, high blood pressure and skin cancer. 

Additionally, in order for immunosuppressants to work effectively, they need to be taken at the same time every day, and the dose is very precise. Too much or too little in your bloodstream can be dangerous. The AST survey also found nearly 40% of respondents missed a fill or refill in the past year due to costs. Also, more than 1 in 4 patients said they "sometimes" or "often" skipped or reduced doses because of costs. The burden of making sure they get the right amount of medicine at the right time falls on the transplant recipient, which often causes anxiety and stress. This can also be complicated by changes in the dosage of immunosuppressants, which happen often based on the person's health. 

While a transplant may not be a cure, breakthroughs like this can make the treatment even better and give people living with a kidney transplant a better quality of life. 

Authors

Meredith Deeley

Meredith Deeley is the communications manager for the American Kidney Fund.