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Research Studies

Patient Studies

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

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, FACS
Study Coordinators: Primary: Nathan Brigle, Secondary: Mary Baldecchi


International Randomized Trial to Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)

Purpose: The purpose of the OCS Liver PROTECT Trial is evaluate if the OCS liver technology is safe and effective in preserving donor livers and to compare the clinical outcomes of the OCS liver device versus cold storage to assess any potential benefits.
Sponsor: TransMedics
Principal Investigator: Chandra Bhati, MD
Study Coordinators: Primary: Mary Baldecchi, Secondary: Nathan Brigle


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.
Sponsor: Johns Hopkins University
Principal investigator: Gaurav Gupta, MD
Study Coordinators: Primary: Nathan Brigle, Secondary: Mary Baldecchi


A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients (Letermovir CMV)

Purpose: The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Dhiren Kumar, MD
Study Coordinators: Primary: Mary Baldecchi, Secondary: Nathan Brigle


Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study (INTERLIVER)

Purpose: The purpose of INTERLIVER is to develop a new diagnostic system that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create an Integrated Diagnostic System.
Sponsor: The Alberta Transplant Applied Genomics Centre (ATAGC)
Principal Investigator: Chandra Bhati, MD
Study Coordinators: Primary: Nathan Brigle, Secondary: Mary Baldecchi


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). Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.
Sponsor: Wake Forest University Health Sciences
Principal Investigator: Gaurav Gupta, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle


Studies of Pediatric Liver Transplantation (SPLIT)

Purpose: The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant.  Collecting this data is expected to help researchers learn more about liver transplant in children.
Sponsor: The Emmes Corporation
Principal Investigator: Adrian Cotterell, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle


A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney (Angion DGF)

Purpose: The major objective is to demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
Sponsor: Angion Biomedica Corp
Principal Investigator: Dhiren Kumar, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle


Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies (INTERCOMEX)

Purpose: The purpose of INTERCOMEX is to develop a new diagnostic system that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create an Integrated Diagnostic System.
SponsorThe Alberta Transplant Applied Genomics Centre (ATAGC)
Principal InvestigatorGaurav Gupta, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle


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.
SponsorVirginia Commonwealth University
Principal InvestigatorGaurav Gupta, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle


Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry (KOAR)

Purpose: This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.
SponsorCareDx
Principal InvestigatorDhiren Kumar, MD
Study Coordinator: Primary: Mary Baldecchi, Secondary: Nathan Brigle