Transplant Institute Clinical Trials & Grants | NYU Langone Health

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Transplant Institute Clinical Trials & Grants

We conduct innovative clinical research that advances transplant medicine.

At NYU Langone’s Transplant Institute, our physicians and researchers conduct clinical trials to develop new treatments and improve outcomes for people who need kidney, liver, heart, or lung transplants.

Below are clinical trials for which we are now seeking enrollees, as well as studies currently in follow-up, a period during which data is collected and patients who were enrolled in the trials are monitored by doctors. For more information about any of these trials, email transplant-institute.research@nyulangone.org.

If you are a researcher who wishes to conduct clinical research at the Transplant Institute, learn about our facilities.

Studies Seeking Enrollees

The following studies are currently enrolling new participants.

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-Mediated Rejection in Kidney Transplant Patients

The purpose of this study is to evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (AMR) in kidney transplant recipients, as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) at six months after treatment initiation.

For additional information about participating in this trial, including eligibility criteria, email principal investigator Bonnie E. Lonze, MD, PhD, at transplant-institute.research@nyulangone.org. See full clinical trial information at clinicaltrials.gov.

A Double-Blind, Randomized-Withdrawal, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Plasma-Derived C1-Esterase Inhibitor as Add-On to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients

This is a double-blind, randomized-withdrawal, placebo-controlled study of kidney transplant patients with antibody-medicated rejection (AMR) to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as an add-on to standard of care, immunoglobulin therapy (IVIG).

For additional information about participating in this trial, including eligibility criteria, email principal investigator Bonnie E. Lonze, MD, PhD, at transplant-institute.research@nyulangone.org. See full clinical trial information at clinicaltrials.gov.

A Phase IIa Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in De Novo Kidney Transplant Recipients

To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids, and bleselumab) compared with the standard of care regimen (basiliximab induction, tacrolimus, steroids, and mycophenolate mofetil [MMF]) in the prevention of the recurrence of focal segmental glomerulosclerosis (FSGS) as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology through three months post-transplant.

For additional information about this trial, including eligibility criteria, contact principal investigator Bruce E. Gelb, MD, at transplant-institute.research@nyulangone.org.

HIV Hope Trial: Prospective Observational Study of HIV-Positive Deceased Donor Transplant for HIV-Positive Kidney and/or Liver Recipients

For additional information about this trial, including eligibility criteria, contact principal investigator Sapna Mehta, MD, at transplant-institute.research@nyulangone.org.

A Prospective Randomized, Multi-Center Study of the Use of the LifePort® Liver Transporter (LLT) System with Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplantations

For additional information about this trial, contact principal investigator Nabil N. Dagher, MD, at transplant-institute.research@nyulangone.org.

A Single-Center Pilot Study of the Use of Hepatitis C-Positive Donors for Hepatitis C-Negative Heart Transplant Recipients with Post-Transplant Treatment of Hepatitis C Viremia with Mavyret

For additional information about this trial, contact principal investigator Alex Reyentovich, MD, at transplant-institute.research@nyulangone.org.

Pilot Program for the Preservation of Organ Donation in Imminent Neurological Deaths at Bellevue Hospital and NYU Langone Hospitals

For additional information about this trial, contact principal investigator Luis F. Angel, MD, at transplant-institute.research@nyulangone.org.

A Single-Center Pilot Study of the Use of Hepatitis C-Positive Donors for Hepatitis C-Negative Lung Transplant Recipients with Post-Transplant Treatment with Mavyret

For additional information about this trial, contact principal investigator Luis F. Angel, MD, at transplant-institute.research@nyulangone.org.

Studies with Subjects in Follow-Up

These studies are closed to enrollment; subjects are currently in follow-up.

A Phase II Study to Evaluate the Efficacy of IdeS (IgG endopeptidase) to Desensitize Transplant Patients with a Positive Crossmatch Test

The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone unsuccessful desensitization or in whom effective desensitization is highly unlikely. At study entry, patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing donor-specific antibodies (DSAs) and thereby convert a positive crossmatch test to negative.

For additional information about this trial or upcoming trials for highly sensitized patients, email principal investigator Robert Montgomery, MD, DPhil, at transplant-institute.research@nyumlangoneorg. See full clinical trial information at clinicaltrials.gov.

A Phase II Randomized, Multi-Center, Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High-Risk Orthotopic Liver Transplant (OLT) Recipients with Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high-risk patients following a liver transplant. Liver transplantation is a treatment option for patients who have liver cancer, but despite transplantation, cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high-risk patients following a liver transplant.

For additional information about this trial, email transplant-institute.research@nyulangone.org. See full clinical trial information at clinicaltrials.gov.

A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection

This registry will enroll cirrhotic subjects with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a SOF-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study. The participants are being followed for up to five years.

For additional information about this trial, email transplant-institute.research@nyulangone.org. See full clinical trial information at clinicaltrials.gov.

A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AILD)

The primary objective of this study is to evaluate the safety and efficacy of ELAD with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study terminated (as the last surviving enrolled subject completed Study Day 91).

For additional information about this trial, email transplant-institute.research@nyulangone.org. See full clinical trial information at clinicaltrials.gov.

Grants

Below are grants recently awarded to researchers at the Transplant Institute.

Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

For additional information about this grant, which was awarded by NYU Langone’s Center for Healthcare Innovation and Delivery Science, email transplant-institute.research@nyulangone.org.

Using Patient-Centered Education to Shorten Waiting Time to Kidney Transplantation

For additional information about this grant, which was awarded by NYU Langone’s Center for Healthcare Innovation and Delivery Science, email principal investigator Bonnie E. Lonze, MD, PhD, at transplant-institute.research@nyulangone.org.

Quantifying Risk and Survival Benefit from Incompatible Kidney Transplantation

For additional information about this grant, which was awarded by the National Institutes of Health (NIH), contact principal investigator Robert Montgomery, MD, DPhil, at transplant-institute.research@nyulangone.org.