Fifteen years ago, while driving from Los Angeles to her home in Berkeley, Calif., Diana Mansfield started shaking, sweating and feeling nauseous. The next day, tests revealed that her kidneys had shrunk to about half their normal size.
For the next ten years, Mansfield kept healthy by monitoring her diet, but by 2001, she was feeling the effects of her kidney disease: she was cold and tired all the time and suffered from leg cramps and nausea. It was clear that she was going to need either dialysis or a transplant, and soon.
"It was a shock," says Mansfield. "I imagined my life becoming narrower and narrower, with less and less that I could do."
In a gesture she'll always be grateful for, Mansfield's brother Bill offered her one of his kidneys. While filling out the paperwork for the transplant, she ran into Dr. Flavio Vincenti, a transplant nephrologist, who was starting a trial for a new post-transplant drug called Belatacept (LEA-29Y). He signed her up as his first patient.
Usually, after an organ transplant, the tendency of the body's blood cells is to attack the new organ as an alien object; anti-rejection drugs, such as prednisone and cyclosporine, trick the cells into accepting the organ. Unfortunately, these drugs are also toxic to the body, and can actually harm the new kidney. Additionally, they can carry various other side effects such as unwanted hair growth, the notorious swelling of the jowls known as "moon face" and a weakened immune system.
Belatacept, on the other hand has all of the same benefits with none of the side effects. Not only have kidneys treated with Belatacept been shown to be healthier than ones treated with other post-transplant drugs, patients suffer from less of the other side effects. "We want to make obsolete the drugs that we use today that result in toxicities that shorten the life of the kidney and the transplant recipient," says Vincenti.
When Mansfield was chosen to be part of the Vincenti's control group, she was thrilled. "I was sure I would come through the surgery alright," says Mansfield. "I wasn't looking forward to being on the [traditional] drugs the rest of my life. It would be better than dialysis, certainly better than death, but it wasn't sounding like I was going to be able to lead a normal life."
Today she feels better than she has in 20 years. Mansfield has been on Belatacept for almost five years and is the longest treated patient. She hopes to continue her infusions, which she receives every eight weeks, for the rest of her life. For the first three years, she was also on prednisone, but after she nagged Vincenti, he weaned her off of it, and she has shown no negative effects.
Currently, the trial is in Phase 3, and will go soon to the FDA for approval. Vincenti hopes Belatacept will be on the market within four years. As for Mansfield, she laughs when people call her "noble" for participating in this groundbreaking study. "It wasn't altruism, it was pure self-interest," she insists. "If there was a better drug out there, I wanted to be on it. And Beletacept is a better drug." Still, she says she is proud of her small part in helping get this new drug through the approval process.
Emma Smith is a freelance writer based in San Francisco. Story written in December 2005.
Kidney Transplant Program
400 Parnassus Ave., Seventh Floor
San Francisco, CA 94143
Phone: (415) 353-1551
Pre-Kidney Fax: (415) 353-8708
Post-Kidney Fax: (415) 353-8381