A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Purpose: The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (TRANSFORM)
urpose: This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant (ENLIST)
Purpose: To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Purpose: The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
Purpose: The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Purpose: Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant (ReGIFT)
Purpose: The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).
WP01 - Normothermic Liver Preservation
Purpose: A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.