A Multicenter, Prospective, Open label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart™ Liver Machine Perfusion System with Static Cold Storage for Organ Preservation Prior to Liver Transplantation BTL-2020-01 vs - Version 4.0 dated Sept. 23, 2021,
Role: Investigator,
Bridge to Life, Ltd,
(12/2023 - 08/2024)
Status: Completed
Post-marketing requirement study to evaluate the safety of Octaplas™ versus plasma in patients undergoing orthotopic liver transplantation with special emphasis on hyperfibrinolysis,
Role: Investigator,
Octapharma,
(06/2018 - 06/2019)
Status: Completed
A 24 month, multicenter,randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in denovo renal transplant- advancing renal transplant efficacy and safety outcomes with an eveRolimus- based regimen (TRANSFORM, Jan 2015),
Role: Investigator,
Novartis Pharmaceuticals Corporation,
(02/2018 - 02/2019)
Status: Completed
A prospective observational trial to evaluate the correlation of T-SPOT® response to CMV infection and T cell-mediated acute graft rejection. The PROTECT Study (PROTECT, May 2015),
Role: PI,
Oxford Immunotec,
(07/2017 - 07/2018)
Status: Completed
A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of fibrin sealant grifols (FS Grifols) as an adjunct to hemostasis during parenchymous tissue open surgeries (Protocol IG1102 version 2.1: 24 October 2012),
Role: Investigator,
Instituto Grifols, S.A.,
(03/2016 - 03/2017)
Status: Completed
A phase 3, double-blind, double-dummy, multi-center, prospective, randomized study of the efficacy and safety of LCP-Tacro™ tablets, once daily, compared to Prograf® capsules, twice daily, in combination with mycophenolate mofetil for the prevention of acute allograft rejection in De Novo adult kidney transplant recipients (protocol LCP-Tacro 3002 version 3.0 September 30, 2010),
Role: PI,
LifeCycle Pharma A/S,
(10/2013 - 10/2014)
Status: Completed
A phase 2, randomized, open-label, parallel group, multi-center study to assess the safety and efficacy of alefacept in de novo kidney transplant recipients,
Role: PI,
Astellas Pharma US, Inc.,
(01/2011 - 01/2012)
Status: Completed
A phase IV, non interventional, multi-center, open-label, prospective, observational study of the safety, effectiveness, tolerability and compliance of immunosuppressive regimen using mycophenolic acid to treat de novo renal transplant patients in routine clinical practice,
Role: Investigator,
Novartis Pharmaceuticals Corporation,
(05/2010 - 05/2011)
Status: Completed
A Phase III, randomized, open-label, comparative, multi-center study to assess the safety and efficacy of Prograf (tacrolimus)/MMF, modified release (MR) tacrolimus/MMF and neoral (cyclosporine)/MMF in de novo kidney transplant recipients,
Role: Investigator,
Fujisawa,
(02/2009 - 02/2010)
Status: Completed
A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation vs. long term maintenance corticosteroid therapy with Pograf and CellCept in primary renal transplant recipients,
Role: Investigator,
Fujisawa,
(08/2007 - 08/2008)
Status: Completed
Internal
The role of B cells in kidney allograft dysfunction (B cell 3/1/2014),
Role: Investigator,
LLU Transplantation Institute,
(06/2022 - 06/2023)
Status: Completed
Hematologic and Immune Cell Ratios in the Prediction of Outcomes After Solid Abdominal Organ Transplantation,
Role: Investigator,
LLU Dept. of Surgery,
(07/2021)
Status: Approved
Highly Suppressive Regulatory T Cell as a Biomarker for Immunologically Relevant Delayed/Slow Graft Function after Kidney Transplantation,
Role: Investigator,
LLU Dept. of Surgery,
(10/2020)
Status: Approved
Outcomes of kidney transplantation with arterial reconstruction from living donors,
Role: Investigator,
LLU Transplantation Institute,
(04/2008)
Status: Completed
Clinical outcomes of induction therapies in renal transplant patients,
Role: Investigator,
LLU Transplantation Institute,
(12/2007 - 12/2015)
Status: Completed
Liver transplantation in the presence of portal vein thrombosis,
Role: Investigator,
LLU Thyroid Research Fund,
(10/2007)
Status: Completed
Integration of donor-derived cell-free DNA with HLA-DR+TNFR2+ regulatory T cell in the prediction of acute rejection and graft function after kidney transplantation,
Role: Investigator,
American Society of Transplant Surgeons,
(08/2024 - 08/2025)
Status: Approved
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppresion Trial (BENEFIT),
Role: PI,
Bristol-Myers Squibb Foundation, Inc.,
(01/2010 - 01/2011)
Status: Completed
Belatacept evaluation of nephroprotection and efficacy as first-line immunosuppression trial - extended criteria donors,
Role: Investigator,
Bristol-Myers Squibb Foundation, Inc.,
(06/2006 - 06/2007)
Status: Completed