One clinical research trial conducted at
the Saint Barnabas Health Care System Renal and Pancreas
Transplant Division is bringing revolutionary improvements
to the quality of life for kidney transplant recipients
by eliminating steroids from their daily dose of medication.
 "Steroid medications have
been the mainstay of immunosuppression since organ transplant
began in the 1950s," explains Shamkant Mulgaonkar, M.D.,
Chief of the Saint Barnabas Health Care System Renal and
Pancreas Transplant Division. "Attempts at withdrawing
patients from steroids have been associated with very high
rates of organ rejection." Unfortunately, steroids are
fraught with many serious and unpleasant side effects.
Even at the minimum dose, many patients suffer the consequences
of steroids which can include weight gain (20-50 lbs in
a year), change of overall appearance, mood changes, depression,
acne, and hair growth, as well as the development of diabetes,
osteoporosis and cataracts. Patients on steroids are also
at risk for developing high blood pressure, high cholesterol
and infections.
"There has been a tremendous push to develop
something in the immunosuppressive regimen that will avoid
the use of steroids," says Dr. Mulgaonkar. After almost
five years of intensive work, transplant research experts
believed they had designed a suitable protocol that could
virtually eliminate the use of steroids. An extensive clinical
research trial of the Steroid Avoidance Protocol began
in 2003. Transplant patients eligible to participate in
the clinical trial are given a drug called Thymoglobulin
and some steroid medication during surgery and for a few
days following. After three to four days the Thymoglobulin
and the steroid are withdrawn. Transplant recipients then
continue with two standard immunosuppressive agents - Cellcept ® and
Prograf ®.
"The outcomes of the steroid avoidance
protocol have been spectacular," reports Dr. Mulgaonkar. "Patients
experience virtually no weight gain, less development of
diabetes, and their blood pressure is easier to control.
Patients participating in the trial have had lower cholesterol,
no serious infection, and most importantly the rejection
rates are low," he says. Other premier transplant centers
in the United States participating in the trial are reporting
similar results.
Results of the research study have been
published by Dr. Mulgaonkar and presented at international
medical conferences. Based on the favorable outcomes achieved
at Saint Barnabas Medical Center and other transplant centers,
the protocol is now being offered to a broader group of
patients, including those considered high risk.
As a direct result of the Steroid Avoidance
Protocol, a new international study is now underway. Thymoglobulin
and two other drugs, Simulect and Campath, are being tested
and compared for their effectiveness on transplant recipients
with specific medical profiles and medical histories. "It
is one of the best designed double blind research trials," says
Dr. Mulgaonkar, "and our patients are taking advantage
of it. Preliminary outcomes appear to be favorable."
The Saint Barnabas Health Care System Renal and Pancreas
Transplant Division has been conducting clinical research
for more than 15 years. It is now one of the world¡¦s
principle centers for the development of new and improved
medications for organ transplantation.
"Transplantation is among the most dynamic medical
specialties," says Shamkant Mulgaonkar, M.D., Chief of the
Saint Barnabas Health Care System Renal and Pancreas Transplant
Division. "Our participation in scientific research studies
allows our patients to benefit from new technologies, new
techniques, as well as new drugs and new drug combinations,
long before they are available at other transplant centers."
Clinical research requires a tremendous commitment
on the part of transplant centers and the patients. The Renal
and Pancreas Transplant Division follows strict guidelines
for medical research and monitors the patients' health closely.
Informed Consent: Informed consent explains
in clear, non-technical terms the benefits and possible risks
of participating in the clinical research trial. The process
continues throughout the study to provide information to
participating patients.
Collect and Report Data: Collecting
complete and accurate data is an essential part of any clinical
research study. As a trial progresses, researchers report
the results of the trial at scientific meetings, to medical
journals, and to various government agencies.
Internal Review Board: Saint
Barnabas Medical Center and Newark Beth Israel Medical Center
each maintains an Internal Review Board (IRB). An IRB is
an independent committee of physicians, community advocates
and others that ensures a clinical trial is ethical and the
rights of study participants are protected. All institutions
that conduct or support biomedical research involving people
must, by federal regulation, have an IRB that initially approves
and periodically reviews the research.
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