Renal Transplant Clinical Trial
Official title:
A Pilot Study of Corticosteroid-Free, Calcineurin-Sparing Immunosuppression Protocol for HLA-Identical Living Donor Renal Transplant Recipient
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and
calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney
transplant from a living donor that is HLA - identical, or in other words, has a similar
immune system. The immune system is a defense system that the body uses to fight foreign
substances that enter the body, such as a transplanted kidney. Two people with similar
immune systems are less likely to fight off or reject an organ donated from one to the
other. HLA-identical kidney transplant recipients are less likely to need large amounts of
immunosuppression because they are immunologically similar. In this study, you will be
treated with the immunosuppressive medications, Cellcept, Rapamune, and Prograf and after a
rejection free period will remain on Cellcept alone. This treatment regimen is currently
being used at The University of Cincinnati for all HLA-identical living donor kidney
transplant recipients. This study is being conducted to determine if the protocol currently
being used results in beneficial outcomes for HLA-identical kidney transplant recipients.
Only recently have transplant centers considered avoiding steroid therapy (prednisone) in
any transplant patient because steroids have been used successfully for so long, but with
many side effects. The ability to stop steroids has occurred due to the availability of
newer more effective immunosuppressive medications. Stopping steroids has been tried in
patients who are considered to be at both low and higher risk of kidney rejection. Patients
considered at risk for rejection may typically be left on steroids forever or no attempts to
stop the steroids would be made until the patient is one year after transplant and has
already received a lot of steroid therapy resulting in side effects. This study will be
conducted in patients that are low risk for rejection and can potentially benefit from
steroid avoidance.
Overall, the concept of steroid avoidance in patients that are at low risk for rejection is
now much more acceptable because newer, more potent medications have recently become
available to prevent acute rejection. These newer medications include Prograf (tacrolimus),
Cellcept (mycophenolate mofetil), and Rapamune (sirolimus). Currently, most kidney
transplant recipients receive medications consisting of tacrolimus or cyclosporine,
mycophenolate mofetil or azathioprine, and steroids. However, recently, the combination of
Prograf (tacrolimus) and Rapamune (sirolimus) with steroid withdrawal 3 months after
transplantation was studied in patients receiving liver, liver/kidney, and kidney/pancreas
transplants. This study showed a low rate of acute rejection with excellent patient and
kidney survival.
The addition of Cellcept to Prograf and Rapamune is thought to be a safe and effective
alternative to the use of steroids in transplant patients. Due to the low risk of rejection
for HLA-identical kidney transplant recipients, patients in this study will be slowly
withdrawn from both Rapamune and Prograf over a rejection free period of time. Withdrawal of
these medications and avoidance of steroids could decrease the development of high blood
pressure, high cholesterol, diabetes, tremors, and infection after transplant. This study
will determine if this medication regimen is safe, effective, and able to produce beneficial
post transplant outcomes.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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