Inova Fairfax Medical Campus patient takes part in a potentially revolutionary clinical study
For about three years, Don Davis, a 58-year-old Deputy Chief Information Officer who lives in Prince William County, had severe kidney problems. This included living with kidney failure — his kidneys functioned at less than 15 percent of normal capacity — for about a year. He was scheduled to receive a kidney transplant from his sister on May 23, 2018. However, after meeting his surgeon, James Piper, MD, transplant surgeon at the Inova Fairfax Medical Campus (IFMC) Transplant Center, that plan changed slightly.
A new type of transplant
Dr. Piper let Don know about a leading-edge clinical trial in which IFMC is participating. Called the Mercury Study, the goal is to eliminate the need for antirejection medication after the transplant.
“The issues with antirejection medications are threefold,” Dr. Piper explains. “First, they all have side effects. Second, they decrease your immune system, making you more likely to get infections or other health problems. And the third issue is that most transplants won’t last a patient’s full lifetime. The antirejection medications generally allow people to keep a kidney for 10 to 15 years.”
If the procedure being tested in the Mercury Study is successful, it could turn all of these issues into a problem of the past. Referring to it as “the holy grail of transplant,” Dr. Piper explains that the process involves a transplant of DNA from blood stem cells from the donor after the kidney transplant. This can create a state called “mixed chimerism” in the recipient’s body.
“By incorporating DNA from the donor to the recipient after transplant, we’re hoping that the patient’s body will accept the kidney as if it’s just another part of their body,” Dr. Piper says.
Trial participation: an important decision
Dr. Piper explained to Don and his sister, Jill Isenhower, a mother of three and part-time sales representative from Homewood, Alabama, that they were perfect candidates for the trial because they were a perfect match.
“He said we were such a perfect match that if he didn’t know we were brother and sister, seven years apart in age, he would have thought we were identical twins,” Don says.
After going over the process with Don and Jill, they both decided to take part in the study, which is currently occurring in just 37 hospitals across the country, with one donor and recipient pair at each participating hospital. Don and Jill were the first pair to enroll in the study. In addition to being the only non-university affiliated hospitals in the study, IFMC is also the first hospital to have multiple pairs enrolled in this groundbreaking study.
Taking part is personal
While both Don and Jill appreciate the importance of the study in advancing this type of medicine, their reasons for participating were also personal.
“For me, there were two parts,” Don notes. “One, I’ve got nothing to lose. If the trial doesn’t work out, I’m not losing anything because I still have the kidney transplant. And two, I know how difficult it is for kidney transplant patients. I’ve known a few who take the [antirejection] meds and it can damage other organs and cause problems.”
Jill notes that her main concern was the extra trips it would take for her to participate. Living in Alabama with the study based in Virginia meant she would have to spend time away from her children. However, she ultimately made the decision to be a part of it because of the impact it could have on her brother’s life.
“First and foremost, it would be so awesome for him to not have to need another kidney, and not have to worry about the financial burden and the effects all of the drugs have on you,” she says. “Dr. Piper said most of the time when transplant patients end up back in the hospital, it’s because of the medications and not the organ.”
As another positive aspect, going through the process also had an effect on their personal relationship.
“I got to spend more time with [my brother] just from being up there,” Jill says. “I think both of us feel closer than we ever have. Growing up him being seven years older than me — we talk and text more now than we ever have.”
A bright future for transplant participants
As participants in the study, Don received a new kidney from his sister at the end of 2018. Although the motivation to participate in the Mercury Study was more personal for Don and Jill, they both acknowledge that it was important for them to be part of something that could end up helping many people.
“It just makes me feel that it was all worth it,” Don says. “I hope my feedback makes a difference and encourages people. Being part of the study isn’t as important to me as knowing that I will hopefully help other people.”
Feedback provided by Don and Jill is already making a difference. After going through the process, they worked with Dr. Piper to revise some of the procedure protocols, which will make it better for future participants. And so far, Don’s transplant has been a success. He expects to be fully off of antirejection medications by August, about 11 months after his initial surgery.
The trial’s long-term impact
Dr. Piper echoes Don and Jill’s feelings about the study. In addition to potentially providing a much better treatment plan for transplant patients, he also emphasizes the importance of keeping medicine moving forward, and how Don and Jill’s participation is instrumental in that push.
“There are 37 other centers across the country doing this study, but we were the first to enroll a patient,” says Dr. Piper. “The protocol was revised based on our input and [Don and Jill] helped restructure the study’s process. Not only are we at the cutting edge, but we are leading the parade instead of following it.”
It’s exciting for Dr. Piper and his staff — as well as Don and Jill — to be a part of something that so few places can offer. However, as Dr. Piper notes, it’s important to remember that if the study is successful it has huge implications not just for medicine, but for transplant patients.
“If this study is successful it will increase the number of patients who are potentially eligible,” he says. “And this could take us to what we’ve always wanted, which is transplant patients only needing one organ for the rest of their lives.”
Learn More About the Mercury Study for Kidney Transplant
While the treatment in the Mercury Study won’t be widely available to the public for some time, the trial should be enrolling patients for another one to two years. Anyone with interest should contact the Inova Fairfax Medical Campus Kidney Transplant Center.