Patients who are eligible to participate in a clinical trial have the
opportunity to review the study protocol to determine what is expected.
The protocol will list details including the schedule of tests, procedures,
medications, dosages, schedule of doctor appointments and the duration
of the study. Choosing to enroll is a personal decision that requires
careful consideration of the potential advantages and disadvantages
of participation. If you chose to enroll in the study, you will be
asked to sign an informed consent document. This document is not
a contract and you may withdraw at any time. The following describes
an investigational program the kidney transplant program participates
in to help advance transplantation success.
Clinical Trials
Early Steroid
Withdrawal Study verses Long-Term Use of Steroids in Primary
Kidney Transplants (Multi-Center Trial)
Patients who qualify and consent to this study are randomized to Simulect
induction, Prograf, and Cellcept with steroids verses Simulect induction,
Prograf, and Cellcept without steroids. Post transplant rejection rates
as well as long-term complications from steroid use and non-steroid use
are studied in these groups of patients.
FTY720 Study
The goal of this study is to evaluate the effectiveness and safety of
a new anti-rejection medication, FTY720, in combination reduced-dose
or full- dose Neoral and steroids versus mycophenolate mofetil (Cellcept,
MMF) combined with full-dose Neoral and steroids in adult kidney transplant
recipients.
Optima Study
Consenting patients with previous kidney transplants for at least six
months and are on Neoral as an anti-rejection agent, are converted
from Neoral to Prograf to optimize Prograf therapy in maintaining kidney
transplants over the long term.
TAILOR (Thymoglobulin
antibody immunosuppression in living donor recipients
Consenting patients undergoing living donor kidney transplant are evaluated
in the use of an anti-rejection agent, Thymoglobulin, given at the time
of the transplant.
Islet Cell Transplantation
Individuals with insulin dependent diabetes mellitus may be eligible
for islet cell transplantation. Islet cells that are isolated from
a donor pancreas, are infused into the recipient’s liver for
the purposes of producing insulin. Islet cell transplant is an alternative
to whole organ pancreas transplant to produce insulin, regulate blood
sugars and stabilize diabetic complications.
A Registry of Long-Term Outcomes in Kidney
and/or Pancreas Transplant Recipients
A registry has been established
of patients who have had a kidney and or pancreas transplant
in our program and who have consented to the release of
their medical information for the purposes of studying
long-term outcomes and complications after transplant.
Steroid-Free Immunosuppression in Recipients
of Kidney Transplants
The steroid-free anti-rejection
study in patients who have had a kidney transplant (and
consented to the study) is a three-year study to monitor
outcomes in patients who are being managed post transplant
without the use of steroids. This study was initiated in
2002.
Thymoglobulin Induction Therapy for Renal
Transplants
The Thymoglobulin Induction study
purpose is to evaluate the use of Thymoglobulin in a single
dose after transplant as opposed to the alternate day administration.
Patients who meet criteria and who consent to the study
will be randomized to either a single dose of thymoglobulin
or alternate day thymoglobulin.
|
