Current Research Studies

• Cardiopulmonary Exercise Testing

  Study title: Cardiopulmonary Exercise Testing in the Evaluation of Lung Transplant

  • Principal investigator: David Nunley, MD
  • Overview: This investigation is designed to determine which physiologic parameters denoting physical fitness may be associated with improved outcomes following lung transplantation.  Additionally, the study is designed to determine which of these parameters may further be improved via pre-transplant rehabilitation. All study participants have two non-invasive cardiopulmonary exercise tests performed which are separated by an interval of Pulmonary Rehabilitation. All candidates for lung transplantation are potentially eligible for enrollment.

• Donor Quality Study

  Study title: Donor Quality Study: American College of Chest Physicians Lung Transplant Research Consortium

  • Principal investigator: David Nunley, MD
  • Overview: This investigation is conducted as part of a consortium that consists of 13 lung transplant centers throughout the United States, and is designed to identify factors that help transplant physicians in their decision to accept or decline donor lungs for transplantation. Phase 2 of this investigation will involve using predictive models to better standardize donor lung acceptance for transplantation.

• Novel Markers of Human Lung Disease

  Study title: Identification of Novel Markers of Human Lung Disease

  • Principal investigator: Megan Ballinger, PhD
  • Overview: This study examines the role of specific cell types in regulating lung diseases such as interstitial lung disease, chronic obstructive pulmonary disease and pulmonary hypertension. Cells are isolated from a diseased lung post-transplantation and measured for a variety of parameters including production of cellular mediators, expression of genes important in signal transduction pathways, functionality of cells, viability and proliferation. Data collection from these cells will provide essential information regarding cellular dysfunction and dysregulation during lung disease and will enable the development of novel therapeutics

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• Apellis

  Study title: Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALIANT)

  • Principal investigator: Todd Pesavento, MD
  • Overview: A Phase 3, Randomized, Placebo Controlled, Double Blinded, Multi center Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune Complex Membranoproliferative Glomerulonephritis

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• FREEDOM-1 (Talaris)

  Study title: FREEDOM-1 (Talaris)

  • Principal investigator: Todd Pesavento, MD
  • Overview: Evaluation of safety, efficacy and immunosuppression therapy following FCR001 cell therapy after kidney transplant vs standard of care

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• IMAGINE Study

  Study title: Interleukin 6 Blockade Modifying Antibody-Mediated Graft Injury and eGFR Decline (IMAGINE)

  • Principal investigator: Todd Pesavento, MD
  • Overview: 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

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• Simultaneous Liver-Kidney Transplantation (SLK)

  Study title: SLK (Simultaneous Liver-Kidney Transplantation) Trial

  • Principal investigator: Austin Schenk, MD, PhD
  • Overview:
    • Over- or Underutilization of Simultaneous Liver-Kidney Transplantation? Use of Renal Scintigraphy to Measure Native Kidney Recovery
    • Renal injury frequently accompanies chronic liver disease and renal recovery following liver transplantation is variable. In select patients simultaneous liver kidney transplantation (SLK) can ensure adequate renal function in the post-transplant period. Poor renal function correlates with increased mortality after liver transplantation and motivates desire for simultaneous liver-kidney transplantation (SLK). Overuse of SLK, however, misappropriates valuable renal allografts and is unfair to patients on the renal transplant waitlist. This complex problem of just allocation of renal allografts to liver transplant candidates with impaired renal function is further complicated by the difficulties of predicting native renal recovery following liver transplantation and the scarcity of studies that actually measure native renal recovery. We propose to utilize renal scintigraphy in SLK recipients to address just utilization of renal allografts.
    • Study funded by The Ohio Solid Organ Transplantation Consortium (OSOTC)
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• AlloSure: KOAR

  Study title: Evaluation of Patient Outcomes from the Kidney Allograft Outcomes AlloSure Registry (KOAR)

  • Principal investigator: Todd Pesavento, MD
  • Overview: This observational registry evaluates patient outcomes in kidney transplant recipients who undergo regular use of AlloSure testing.  The registry will provide information on outcomes of patients who undergo monitoring for rejection using AlloSure in clinical practice compared to outcomes in patients who are not monitored for rejection using AlloSure.

• APOL1: Kidney

  Study title: APOL1 Kidney Transplant Outcomes

  • Principal investigator: Todd Pesavento, MD
  • Overview: APOL1 Long-term Kidney Transplant Outcomes Network

• Fecal Microbiota Transplantation

  Study title: Fecal Microbiota Transplantation for C. Difficile

  • Principal investigator: Todd Pesavento, MD
  • Overview: Fecal Microbiota Transplantation For C. Difficile Infection in Solid Organ Transplant Recipients

• Letermovir vs. Valganciclovir for Prevention of CMV in Kidney Transplant Recipients

  Study title: 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

  • Principal investigator: Alejandro Diez, MD
  • Overview: The purpose of this study is to evaluate the efficacy of letermovir versus valganciclovir, as measured by the proportion of participants with adjudicated CMV disease through post-transplant week 52.

• Long Term Outcomes of Living Donation or ALTOLD

  Study title: Assessing Longterm Outcomes of Living Donation or ALTOLD 

  • Principal investigator: Todd Pesavento, MD
  • Overview: The purpose of this study is to thoroughly evaluate the long-term risk, if any, of kidney donation. Specific aims are glomerular filtration rate, risk factors for cardiovascular disease and proteinuria in healthy controls compared to subjects post-unilateral nephrectomy. This is a longitudinal study follow-up is occurring at eight sites and has been approved for nine years of follow-up

• Cinryze® for the Treatment of Acute Antibody-Mediated Rejection

  Study title: 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

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: This is a multicenter, multinational study evaluating the efficacy of 20,000 total units of Cinryze given intravenously in seven doses over 13 days as an adjunct to plasmapheresis and intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopahty (TG) within six months

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• Sirolimus and Everolimus in Combination with Low Dose Cyclosporine

  Study title: Differentiating Sirolimus and Everolimus in Combination with Low Dose Cyclosporine in De Novo Kidney Transplant Patients—The Effects on Vascular Endothelial and Kidney Function

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: This is an optional sub-study for patients enrolled in the Zortress vs. Rapamune research study with Dr. Pelletier. For this sub-study we are working with a researcher at the University of Colorado, Uwe Christians, MD, to extend the Zortress vs Rapamune study into the laboratory. By extending the study into the laboratory we will be able to test plasma from transplant patients for specific molecular markers related to kidney and vascular function. This testing will allow us to see how different medications affect these molecular markers and thus how different medications affect kidney and vascular function

• Comparing Everolimus and Sirolimus in Renal Transplant Recipients

  Study title: A Prospective, Randomized, Single Center Pilot Study Comparing Patient and Graft Survival, Adverse Events and Tolerability of Zortress® (Everolimus) Versus Rapamune® (Sirolimus) in Combination With Low Dose Neoral® (Cyclosporine) Dosed by C2 Monitoring, in Deceased and Living Donor Renal Transplant Recipients Under a Thymoglobulin® (Antithymocyte Globulin) and Rapid Steroid Induction Protocol.
  

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at one year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above

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• Hemostatic Abnormalities

  Study title: Potential Use of Rotational Thromboelastometry to Explore Hemostatic Abnormalities in Patients with Acute Liver Failure (ALF-ROTEM) 

  • Overview: Observations suggest that patients with ALF maintain normal global hemostasis under most conditions, and offer mechanisms whereby the “bleeding tendency” may actually be a tendency to clot. These studies have the potential to show that administering pro-hemostatic factors does not decrease post-procedural bleeding complications, but may adversely affect outcome, contrary to common belief

• Islet Allotransplantation in Type 1 Diabetes

  Study title: Islet Allotransplantation in Type 1 Diabetes

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: This is a single center, prospective, phase one study investigating the use of islet transplantation for the treatment of type 1 diabetes in subjects receiving islets alone or islets after kidney transplant. The aims of this study are to determine the safety of islet transplantation, to determine whether islet transplantation will reduce the frequency of severe hypoglycemia events, to determine whether a steroid-free immunosuppressive protocol will prevent rejection in islet transplants and to achieve insulin independence after islet transplant. A total of 20 subjects will be transplanted with a 12-month follow-up after the last transplantation.

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• Collaborative Islet Transplant Registry

  Study title: Collaborative Islet Transplant Registry

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: A multi-center study designed to collect and analyze data on both allogeneic and autologous islet transplant patients and outcomes allowing for a comprehensive analysis that will identify risk factors and determinants for success to help move the field forward.

• Advancing Treatment for Pancreatitis

  Study title: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST Study)

  • Principal investigators:  Luis F. Lara, MD and Melena Bellin, MD, University of Minnesota
  • Overview: A prospective data gathering trial of patients undergoing total pancreatectomy and auto islet transplantation