Pilot Study for HLA Identical Living Donor Renal Transplant Recipients
Condition: Renal Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): calcineurin inhibitor; sirolimus; mycophenolate mofetil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Calcineurin Inhibitors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney disease; Renal transplant; HLA Identical; Living Donor; Corticosteroid free; Calcineurin sparing; Adults