Simulect Versus ATG in Sensitized Renal Transplant Patient
Condition: Renal Transplant Rejection
Study type: Interventional
Phase: Phase 4

Summary: 
      Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte
      globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies
      (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially
      in highly sensitized patients. Both induction therapy regimens have a different tolerance
      profile. Infections and haematological side-effects are more frequently reported in patients
      receiving ATG.

      The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo
      sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific
      antibodies (DSAs) detected by Luminex.
    

Detailed description: 
      Acute rejection after kidney transplantation can lead to graft loss by irreversible acute
      rejection or to interstitial fibrosis/ tubular atrophy that can induce graft loss. Induction
      therapy by either T-cell depleting polyclonal antibodies such as Anti-Thymocyte Globulins
      (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies (anti-CD25 moAb:
      basiliximab or daclizumab) are used to prevent acute rejection, especially in highly
      sensitized patients. Both induction therapy regimens have a different tolerance profile.
      Infections and haematological side-effects are more frequently reported in patients receiving
      ATG. With respect to the efficacy, no comparison exists between both induction therapy
      regimens in high risk immunological patients as actually defined. Within the last few years,
      the development of new immunological screening tools, i.e. Luminex assay, had lead to a
      better evaluation of the immunological status of candidates for kidney transplantation,
      mainly those who were considered as highly sensitized. The aim of our pilot study is to
      evaluate ATG and basiliximab induction therapy in de novo sensitized kidney-transplant
      patients (incompatible grafts rate ≥ 50%) without Donor Specific Antibodies (DSAs) detected
      by Luminex. Maintenance immunosuppressive regimen will be based on the combination of
      tacrolimus, mycophenolate sodium and steroids. The primary endpoint is a composite of
      biopsy-proven acute rejection, graft loss, loss of follow up, or death at 6 months
      post-transplant. The secondary endpoints are the efficacy of the therapy at month 12
      posttransplant, and safety parameters (CMV infection, BK virus nephropathy, haematological
      tolerance, Adverse Events (AE)and Serious Adverse Events (SAE)). Our hypothesis is that
      basiliximab induction therapy may be sufficiently effective to prevent acute rejection in
      sensitized patients without DSA. This may reduce the post-transplant
      immunosuppression-induced side-effects.
    

Intervention name(s): Simulect; ATG Fresenius
Intervention type(s): Drug; Drug
Intervention description(s): Simulect IV 40 mg/day D0 and D4
and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg; Simulect IV 40 mg/day D0 and D4 and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg
Other intervention name(s): Simulect IV 40 mg/day D0 and D4; and oral use Tacrolimus 0.1 mg/ kg/ day +; Myfortic 720 to 1440mg +; Corticosteroids 5mg; Simulect IV 40 mg/day D0 and D4; and oral use Tacrolimus 0.1 mg/ kg/ day +; Myfortic 720 to 1440mg +; Corticosteroids 5mg
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney transplant; luminex method; simulect ATG; immunosuppression