Investigators - Clinical/Translational - leca

Nicolae Leca, MD

Project 1:Evaluation of the benefits and risks in maintenance renal transplant recipients following conversion to Nulojix (belatacept)-based immunosuppression

This is a randomized, open-label, active controlled, parallel-group trial to assess the safety and efficacy of conversion from CNI (tacrolimus or cyclosporine) to belatacept in post-transplant renal transplant recipients (6-36 months post-transplant) and to compare function graft survival of belatacept- converted patients versus patients continued on CNI based immunosuppression at 24 months post-randomization. Six to ten patients are to be enrolled at UWMC.

Project 2: Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM) 

This is a 2 year, randomized, multicenter, open-label, 2-arm study is designed to evaluate graft function of everolimus and reduced calcineurin inhibitor (CNI) versus mycophenolate and standard calcineruin inhibitor in adult de novo renal transplant recipients. Consented subjects will be randomized (1:1 between the two treatment groups) into the 24-month treatment period. Randomization will be stratified by donor type and CNI usage. The endpoint represents an attempt to assess the clinical balance between having sufficient immunosuppression to prevent rejection while keeping CNI levels low enough to avoid nephrotoxicity. Approximately ten patients are to be enrolled at UWMC.

Project 3: Evaluation of Acute Rejection Rates in de novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-Free, Nulojix (belatacept)-based Immunosuppressi

This is a 2 year, Phase IIb, randomized, multicenter, open-label, 2-arm study designed to assess the incidence of acute rejection by 6 months in de novo renal transplant recipients treated with belatacept-based regimens, which includes thymoglobulin induction, mycophenolate mofetil (MMF) or everolimus and corticosteroids;This trial will also asses the effects of each immunosuppression regimen and the difference between them on the trial designated clinical parameters. Consented subjects meeting eligibility criteria will be randomized (1:1 between the two treatment groups) into the 24-month treatment period with a subsequent 8-week follow-up period for safety post last dose of for all subjects. Six to ten patients are to be enrolled at UWMC.

Project 4: A randomized, parallel-group, double-blind, placebo-controlled, multi-center study of eculizumab for the prevention of delayed graft function after kidney transplantation in adult subjects at increased risk of delayed graft function

This is an 1 year, Phase II/III study to demonstrate the efficacy and safety of a 2-dose regimen of eculizumab given to prevent delayed graft function (DGF) in adult recipients of deceased donor kidney transplants who are at increased risk of DGF. An estimated total of 286 subjects will be randomized (1:1) to either Eculizumab IV versus matching placebo. Approximately eight to ten patients are to be enrolled at UWMC.

Current Funding

Evaluation of the benefits and risks in maintenance renal transplant recipients following conversion to Nulojix(belatacept)-based immunosuppression (PI: Leca)(2013-Present)

Past Funding

Multicenter, Retrospective Database Analysis of Adult Renal Transplant Outcomes from the Northwest Kidney Transplant Consortium in collaboration with OHSU and UC Davis (PI: Leca) (2011-2013)

A 12 month, multicenter, randomized, open-label non-inferiority study comparing the safety and efficacy of concentration-controlled Everolimus with low dose tacrolimus to Cellcept with standard dose tacrolimus in de novo renal transplant recipients (PI:Leca)(2010-2013)

Comparison of Myfortic and Early Sirolimus Conversion vs. low-Dose Tacrolimus in Preventing Acute Rejection and Chronic Allograft Fibrosis: A Protocol Biopsy Directed Approach. Investigator initiated in collaboration with University at Buffalo, NY (PI: Leca)(2010-2011)

MyGain Multicenter Study. Sponsor: Novartis (PI: Leca)(2007)

IL14: Signification and Applications in Transplantation. Empire State Clinical Research Grant. New York State. (Supervisor Oleh Pankewycz, MD)(2004)

Current Research Members

Kelly Yim, CCRC
Kelly is an ACRP nationally certified clinical research coordinator since 2005. She has been a senior research coordinator managing transplant focused clinical trials with UWMC transplant program since 2008. Her previous research administration experience supporting clinical investigators includes studies in immune-mediated diseases, registries and repositories for Translational Research.

Publications

Pub Med provides a list of Dr. Nicolae Leca's research publications

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