Choosing to enroll in a research study 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 investigational programs the kidney transplant program participates in to help advance transplantation success.

Clinical Research 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.

Options to Reduce Transplant Waiting Periods
The current kidney allocation policy considers characteristics of both the donor and the transplant candidate in allocating kidneys equitably. A combination of factors determines who receives which organ including length of time on the waiting list, tissue match between the donor and the recipient, blood type, antibody levels, and whether the recipient is a child.

Every year the transplant waiting list grows but the number of organs has not increased to meet the demand. Transplant programs are constantly ooking for ways to “expand” the donor pool. At The Nebraska Medical Center, we offer a variety of ways to expand that pool, including living donation, laparoscopic donor nephrectomy, anonymous donor program, paired exchange transplants, as well as expanded criteria donor transplants and the use of antibody reduction techniques which are described below.

Expanded Criteria Donors
Although the kidneys that are most commonly transplanted come from previously healthy donors between the ages of 18 and 60, kidneys from other donors with a wide range of characteristics have been successfully transplanted and are called expanded criteria donors. Donors that fall into this less traditional category are defined as:

• Age 60 or older
• Between the ages of 50-59 with at least two of the following conditions:
• History of high blood pressure
• Creatinine level greater than 1.5 (creatinine levels measure how well a kidney is functioning. Normal range is 0.8-1.4)
• Cause of death due to a cardiovascular condition (stroke or aneurysm)

Patients who are most likely to benefit from this option include:

• Patients who are not doing well on dialysis
• Patients who are likely to wait a long time on the waiting list and are at risk of developing serious complications or even death if they continue to wait for a transplant.

By agreeing to accept an expanded criteria donor, you may shorten the waiting period for a transplant. However, there is a greater chance that the donor kidney may not function as well or as long. It is essential that you discuss your individual situation with your transplant team. It is also important to know that agreeing to accept an expanded criteria donor does not mean that you will not be considered for standard donor opportunities. The expanded criteria donor option will be discussed with individuals undergoing transplant evaluation and consent will be obtained for those interested in considering this option.

Antibody Reduction
Antibody reduction provides another option to improve a patient’s ability to be transplanted. Many patients waiting on the list for transplant are considered “sensitized”. Sensitized patients are individuals who have developed antibodies in their blood against foreign tissue. These antibodies develop from previous exposure to foreign tissue such as a previous transplant, pregnancy or blood transfusions. These antibodies interfere at the time of cross match between the donor and recipient’s blood causing a “positive” or incompatible cross match and predict that the transplant has little chance of success. Sensitized patients may wait three or four times longer than unsensitized patients for a compatible cadaver transplant. Antibody reduction removes the antibodies in the recipient’s blood prior to the transplant to enable a successful live donor transplant.