Immunosuppression With Antithymocyte Globulin, Rituximab, Tacrolimus, Mycophenolate Mofetil and Sirolimus, Followed by Immunosuppression Withdrawal, in Living-donor Renal Transplant Recipients (ITN039ST)
Kidneys remove excess fluid and waste from the blood. When kidneys lose their filtering
ability, dangerous levels of fluid and waste accumulate in the body — a condition known as
kidney failure. There are two ways to treat kidney failure. One way is to get dialysis
indefinitely. The second way is to get a kidney transplant. A kidney transplant is often
the best treatment for kidney failure. A kidney transplant is a surgical procedure to place
a healthy kidney from a donor into a person whose kidneys no longer function properly. This
study is for people who will receive a kidney transplant from a very well matched, living
blood relative. The immune system is the body's defense system against illness. After
transplant, the immune system will think that the new kidney is a foreign invader and will
try to attack or reject the transplanted kidney. Immunosuppressive drugs protect the
transplanted kidney by suppressing the immune system. People who have kidney transplants
must take immunosuppressive drug for the rest of their lives. If they stop, their immune
system may reject the transplanted kidney. Immunosuppressive drugs make it hard for the
body to fight off infections. In addition, they can cause high blood pressure, kidney
damage, plaque build-up in the blood vessels, high cholesterol, diabetes and bone disease.
They may also make the body more likely to get some types of cancer (mainly cancer of the
white blood cells and/or skin) and other serious side effects.
Because of the side effects of immunosuppressive drugs, an important goal of transplant
research is to allow people to accept their transplanted organ without always having to take
immunosuppressive drugs. This is called tolerance. The RESTARRT study is testing a
combination of two medications, rituximab and anti-thymocyte globulin (ATG), to see if they
can help people reduce or eliminate the need for life-long immunosuppressive medications.
ATG has been used for over 10 years to treat transplant rejection; rituximab is used to
treat rheumatoid arthritis and two types of cancer. ATG works on immune cells called 'T
cells' that are involved in transplant rejection, while rituximab works on a different type
of cell called 'B cells.' Researchers hope that targeting both these cell types at the same
time will help reset the immune system so that it accepts the transplanted kidney.
Frequent visits are required during the first two months of the study. Then, study visits
take place about every 4 weeks, but more often (every 2 weeks) when reducing medication
doses. After two years, participants will be asked to return for check-ups every 3 months.
Study visits may include consultations with the transplant doctors, physical exam, blood
and/or urine samples and kidney biopsies at several times during the study. In all,
participation could last up to 4 years. All study-related medications and tests are provided
at no charge to the patient.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of subjects successfully withdrawn from immunosuppression
defined as those who remain off immunosuppression for at least 52 weeks
52 weeks after stopping all immunosuppression
James Markmann, MD, PhD
Massachusetts General Hospital
United States: Federal Government
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Maryland Medical Center||Baltimore, Maryland 21201-1595|
|University of California San Francisco Medical Center||San Francisco, California 94143|
|Hospital at the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Rogosin Institute/New York Presbyterian-Cornell||New York, New York 10021|