UW Transplant Program - Clinical Trials

Kidney Transplants (enrolling at the time of the transplant)

For more information and to see if you may qualify for these studies,
please contact the Transplant Clinical Research office at: (608) 263-2565

Study #1

Title: A study using Campath-1H to avoid using a calcineurin inhibitor (cyclosporine or tacrolimus) after a kidney transplant (CEL 484) PI: Hans Sollinger, MD

Eligibility Criteria

Male and females ages 18 and older who are receiving a new kidney transplant
No history of Hepatitis B or Hepatitis C
No cancer history in the past 5 years (except skin cancer)

Study Summary

The University of Wisconsin Transplant Department is conducting a research study to see if kidney transplant recipients who receive a new type of anti-rejection medication called Campath-1H can take one fewer anti-rejection medication each day (either cyclosporine or tacrolimus), and improve their kidney function. Usually kidney transplant recipients take either cyclosporine or tacrolimus every day to help prevent rejection of the transplanted kidney. However in this study, subjects will not take either cyclosporine or tacrolimus therapy. Instead, Campath-1H will be given in combination with Rituximab (an antibody medication made of proteins, prednisone (a steroid), CellCept®, and without cyclosporine or tacrolimus. In this study we hope to learn more about how Campath-1H can prevent rejection of kidney transplants, and help us to understand whether individual responses to treatment with Campath-1H (without the use of either cyclosporine or tacrolimus), are related to any particular proteins found in the blood or kidney tissue of kidney transplant recipients.

If you choose to participate in the study, and you are eligible, you will have a study visit (Day 0) on the day that you enroll in the study and at Days 7, Months 1, 3, 6, 12, and 24 after starting the study. You will have a brief physical examination and your vital signs (blood pressure, temperature and pulse) will be measured at every visit. Blood and urine tests will be obtained at every study visit to monitor your health and the health of your kidney. A special urine sample will also be collected from you everyday while you are in the hospital recovering from your transplant surgery. You will also have a biopsy of your transplanted kidney at your Month 12 study visit, in order to check the health of your transplanted kidney.

Study #2

Title: A study of fixed dose versus concentration controlled CellCept® for new kidney transplant recipients (Roche Study # ML17225)PI: John Pirsch, MD

Eligibility

Male and females ages 18 to 75 years of age who are receiving a new kidney transplant
No history of Hepatitis B or Hepatitis C
No cancer history in the past 5 years (except skin cancer)

Study Summary

This research study is being done to evaluate the safety and effectiveness of using therapeutic drug monitoring of CellCept® (mycophenolate mofetil) to determine the dosage (amount) of this medication for subjects to take each day, as compared to dosing of CellCept® as a fixed dosage. Therapeutic drug monitoring means that you have a blood sample drawn to measure the amount of the medication in your bloodstream. Depending on the results of the blood sample, the dosage of the medication is then adjusted (increased, decreased, or is unchanged) in order to reach a specific blood level. With therapeutic drug monitoring, a blood sample is drawn just before your next scheduled dosage of the medication. In some cases, multiple blood samples are drawn over a number of hours to measure the amount of the drug. The purpose of therapeutic drug monitoring is to give enough of a drug for it to be “effective” and avoid giving too much of a drug, so that the subject does not experience unpleasant drug related side effects.

By random selection, one third of the study subjects will be assigned (Group A) to receive CellCept® (mycophenolate mofetil, MMF) with the dosage of this medication to be determined based on the blood levels of this medication. Subjects in this group will also receive reduced doses of either cyclosporine or tacrolimus (about 1/2 of the usual doses of cyclosporine or tacrolimus used at this transplant center). One third of the subjects will be assigned to Group B, and will receive CellCept® with the dose of this medication to be determined based on blood levels of the medication. However, subject in Group B will receive standard doses of cyclosporine or tacrolimus. The remaining one third of the study subjects will be assigned to Group C, and will receive standard dosing of CellCept® (1000mg twice daily), and standard doses of either cyclosporine or tacrolimus.

If you choose to participate in this study, you will have a baseline study visit to determine if you are eligible to be in the study. If found to be eligible for the study, you will then have 9 additional study visits during the next 24 months after your transplant. At each study visit, you will have study blood tests performed to check your health and the health of your kidney. You will also be asked about any health problems you have noticed since your last study visit. At seven of the study visits you will also have a series of 3 blood samples drawn over a 2 hour period of time, to measure the amount of CellCept® in your blood stream.

Study # 3

Title: The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients (ITN013ST) PI: Stuart Knechtle, MD

Eligibility Criteria

Male and Female patients ages 18-65 years of age receiving a first renal transplant
Must be receiving at least a 3 out of 6 antigen matched kidney
No history of HIV, Hepatitis B or Hepatitis C
No history of cancers (other than skin cancer)

Study Summary

This research study is being done to look at the safety and effectiveness of using Campath-1H, in combination with tacrolimus and sirolimus for the prevention of acute rejection after kidney transplantation. This study will also evaluate whether this combination of medications will allow study subjects to eventually stop taking anti-rejection medications completely, without having rejection problems. If you decide to participate in this study, you will receive a total of three intravenous doses of Campath-1H during the first week after the transplant. You will also take two other standard anti-rejection medications, sirolimus (Rapamune®) for at least 12 months after your transplant and tacrolimus (Prograf®) for at least 60 days after your transplant to prevent rejection of your transplanted kidney.

In this study you will have between 20 and 34 study visits over the next 48 months. You will have a study visit within 24 hours before your transplant and then an additional 13visits during the next 12 months after your kidney transplant. If you participate in the main portion of this study, you will have study visits every six months between months 13 to 48 (for a total of 20 visits) If you participate in the withdrawal portion of this study, you will have visits 2 to 3 times a month for the first 3 months (month 13-15), then monthly for months 16 to 24. You will have a visit on month 27, then from month 30 to 48, you will have visits every 6 months (for a total of 34 visits). At each study visit you will have blood and urine tests performed and at several visits you will have a physical examination to make sure that you are doing well. You will be asked about any health problems you have noticed at each visit.

If you are doing well after your transplant and have not had any rejection problems, you will have a kidney biopsy performed at the Month 12 visit to check the health of your kidney. At that time, if you qualify and give written consent (in a separate consent form), your dose of sirolimus may gradually be reduced after the Month 12 study visit and then stopped completely, about 3 months later. You will then have another kidney biopsy at 6 and 12 months after stopping sirolimus, and then each year, until the end of the study.