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Research Studies

Patient Studies

To learn more about these studies, please contact Mary Baldecchi at mary.baldecchi@vcuhealth.org

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia.

Purpose: VX-880 is an investigational allogeneic human stem cell-derived islet cell therapy that is being evaluated for patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. The VX-880 clinical trial involves an infusion of fully differentiated, functional islet cells, as well as the administration of concomitant immunosuppressive therapy.
Sponsor: Vertex Pharmaceuticals Incorporated
Principal Investigator: Marlon Levy, MD
Study Coordinators: Mary Baldecchi, RN


A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors (the FREEDOM-1 study)

Purpose: The trial will evaluate the safety and efficiency of a single dose of FCR001, an investigational cell therapy, combined with stem cells to hopefully eliminate the need for kidney transplant recipients to take anti-rejection drugs and to remain free from rejection of their transplanted kidney.
Sponsor: Talaris Therapeutics, Inc.
Principal Investigator: Gaurav Gupta, MD
Study Coordinators: Mary Baldecchi, RN


A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients

Purpose: The purpose of this research study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo in kidney transplant recipients with Chronic Antibody Mediated Rejection (CABMR).
Sponsor:CSL Behring
Principal investigator: Gaurav Gupta, MD
Study Coordinators: Mary Baldecchi, RN


Phase 2 multicenter, randomized, double-blind, placebo-controlled, multiple dosing interval, 3-period study of the safety, tolerability and effectiveness of adoptively transferred Viralym-M multivirus-specific T cells in kidney transplant recipients with either high or low levels of BK viremia

Purpose: The purpose of this study is to compare the safety and tolerability of an investigational product, Viralym-M (also known as ALVR105), with placebo and to find out which is better at suppressing BK viral load in kidney transplant recipients.
Sponsor: AlloVir
Principal Investigator: Gaurav Gupta, MD
Study Coordinators: Joyce Ruddley, RN


Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS™) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation (OCS™ Liver DCD Trial)

Purpose: The purpose of the OCS Liver DCD Trial is evaluate if the OCS portable warm liver pump technology is safe and effective in preserving DCD liver donors.
Sponsor: TransMedics
Principal Investigator: David Bruno, MD
Study Coordinators: Mary Baldecchi, RN


APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

Purpose: The APOLLO study is being done to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.
Sponsor: The National Institute of Health (NIH)
Principal Investigator: Gaurav Gupta, MD
Study Coordinator: Shawn Fenner, RN


HIV Positive Kidney Transplants for HIV Positive Patients (HOPE ACT)

Purpose: This research is being done to learn whether organ transplantation from HIV-positive deceased donors is as safe and effective in HIV-positive recipients as transplants from HIV-negative deceased donors.
Principal Investigator: Gaurav Gupta, MD
Study Coordinator: Mary Baldecchi, RN


Collaborative Islet Transplant Registry (CITR)

Purpose: The mission of the Collaborative Islet Transplant Registry (CITR) is to expedite progress and promote safety in islet/beta cell transplantation through the collection, analysis, and communication of comprehensive and current data on all islet/beta cell transplants performed in North America, as well as some European and Australian centers.
Sponsor: The Emmes Corporation
Principal Investigator: Marlon Levy, MD
Study Coordinator: Mary Baldecchi, RN


Registry for the Study of Organ Transplants from Hepatitis C Infected Donors (Reform HepC)

Purpose: The purpose of this research study is to collect and store data regarding safety and outcomes of accepting organ transplants from donors infected with hepatitis C for other research studies in the future. This information will become part of a registry that will help researchers understand the short- and long-term outcomes associated with this medical approach.
Sponsor: Virginia Commonwealth University
Principal Investigator: Gaurav Gupta, MD
Study Coordinator: Mary Baldecchi, RN


The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study

Purpose: This is an observational research study to better understand how Prospera results are used to manage care of patients after a kidney transplant. Prospera measures the amount of donor DNA from a transplanted kidney and this helps the medical team assess for rejection.
Sponsor: Natera
Principal Investigator: Layla Kamal, MD
Study Coordinator: Shawn Fenner, RN


Relationship between donor derived-cell free DNA levels, HLA antibodies, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies in kidney transplant recipients

Purpose: To demonstrate the relationship between cell free DNA levels, HLA antibodies, and the Molecular Microscope® (MMDx) Diagnostic System results in relationship to kidney transplant biopsies.
Sponsor: Natera
Principal Investigator: Layla Kamal, MD
Study Coordinator: Shawn Fenner, RN


Use of dd-cfDNA in Multi-Organ Transplant Rejection Detection (MOTR study)

Purpose: This is an observational research study to better understand how Prospera results are used to manage care of patients after multiorgan transplants. Prospera measures the amount of donor DNA from transplanted organs and this helps the medical team assess for rejection.
Sponsor: Natera
Principal Investigator: Gaurav Gupta, MD
Study Coordinator: Shawn Fenner, RN


Evaluation of Patient Outcomes from the Kidney Allograft Outcomes AlloSure Registry (OKRA and KOAR)

Purpose: OKRA is a multicenter, prospective, observational registry, designed to measure outcomes of kidney transplant recipients managed with KidneyCare. KidneyCare complements AlloSure to include multimodality testing with the addition of AlloMap Kidney Gene Expression Profiling and prognostic graft assessment using iBox.
Sponsor: CareDx
Principal Investigator: Dhiren Kumar, MD
Study Coordinator: Joyce Ruddley, RN


MAPLE

Purpose: The objective of this protocol is to conduct a longitudinal and prospective study of liver transplant recipients using a novel multimodality approach. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and “for cause” biopsy. LiverCare includes a proprietary machine learning algorithm to predict allograft outcomes based on clinical parameters.
Sponsor: CareDx
Principal Investigator: David Bruno, MD
Study Coordinator: Mary Baldecchi, RN


TruGraf Long-term Clinical Outcomes Study (TRULO)

Purpose: The purpose of this study is to evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf® and TRACTM monitoring. TruGraf® and TRAC™ (Viracor) are commercially available blood tests that allow the transplant team to monitor for rejection in kidney transplant recipients.
Sponsor: Transplant Genomics, Inc.
Principal Investigator: Irfan Moinuddin, MD
Study Coordinator: Mary Baldecchi, RN