As a transplant patient, an important part of the daily routine includes taking medications at the correct times and with their proper doses. This is even more important with medications for immunosuppression, which prevent the body from rejecting the new kidney. Although each patient has his own medication schedule, general guidelines are used to prescribe what is best for each individual recipient. These guidelines were developed through research and clinical experience, and continue to improve as newer immunosuppressive agents are developed.

Kidney transplant candidates who are on the waiting list or are scheduled to have a live-donor kidney transplant may be asked to participate in a study which examines three immunosuppressive regimens for the prevention of rejection in patients receiving a kidney transplant. There are many different medications available for prevention of rejection, and most transplant centers, including USC, use combinations of these medications to prevent rejection. Almost all kidney transplant recipients use either Tacrolimus or Cyclosporine as one of the medications. These two medications have similar mechanisms of action and cannot be used together. Both of theses medications are usually taken two times a day by mouth. Modified Release (MR) Tacrolimus is an experimental drug which is taken once a day. In addition to evaluating this medication, three different combinations of medications will be compared. One combination will use the experimental agent MR, one will use Cyclosporine and one will use regular Tacrolimus. All three will also use MMF (Mycophenolate Mofetil) and steroids. The FDA has approved Tacrolimus and Cyclosporine as anti-rejection medications in kidney transplant patients. The FDA has also approved MMF (Mycophenolate Mofetil) but only to be used in combination with Cyclosporine.

The duration of the study will be one year. The patients receiving the study drug, MR, will have the option to participate in a 2 year Extension Treatment Period. The method by which you will be assigned a treatment group is random. That means that it is like flopping a coin. When you are enrolled, an envelope will be opened to tell your doctors which medications you will receive. You have an equal chance of being enrolled in any of the three groups.

During your hospital stay, you will have blood tests drawn. Additional blood tests will be drawn after surgery and again on later months after your surgery, and you will be evaluated by your physician to see how you are feeling, how your kidney is functioning and how you are tolerating the medications. The blood tests that will be obtained will include measures of your blood count, electrolytes, kidney and liver chemistries, medication levels, and cholesterol and lipid levels. These are tests that are routinely done after a kidney transplant and the frequency of testing for this study is very similar to the frequency that is normally required after a routine kidney transplant. In addition to these tests, there will be test that measure blood markers for diabetes and your immune response. These tests will be performed specifically for this study and will be drawn and scheduled for days that your are having your other blood tests.

A quality of life questionnaire is performed at Month 1 and Month 12. This questionnaire will be used to determine the impact of the kidney transplant on your life, and also to determine if there are differences depending upon the medication that your are taking. Once you begin the extension portion of the study, you will be required to come to the clinic for extension study visits according to a schedule: At each visit you will undergo routine examinations including a physical examination, and blood sampling to monitor the safety of the treatment as well as measure the amount of study medication in your blood. The blood tests will be the same as those draw during the first year.