Co-Principal Investigators: Peter Reese, MD, PhD, Therese Bitterman, MD, and Douglas Schaubel, PhD
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The THINKER-NEXT Study will provide Hepatitis C Virus (HCV) infected kidneys to people on the kidney transplant waiting list who do not have HCV, then cure the HCV infection with an antiviral drug with the goal of making more kidneys available to people on the waiting list.
CRC: Uma Krishnan, Clinical Research Coordinator
Email: Uma.Krishnan@pennmedicine.upenn.edu
Phone: 215-746-2484
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the patient is taking either Envarsus XR® (extended release tacrolimus) tablets administered once-daily after transplantation or immediate release generic tacrolimus capsules that are administered twice-daily after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well patients’ blood vessels adapt to each heartbeat. Patients will remain in the study for up to 18 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.
Co-Principal Investigators: Jennifer Trofe-Clark, Pharm D and Roy Bloom, MD
Sponsor: Veloxis Pharmaceuticals
Study team: Lindsay O’Rourke (Lindsay.O'Rourke@pennmedicine.upenn.edu)/215-615-0773;
Ingrid Thone (Ingrid.Thone@pennmedicine.upenn.edu)/215-220-9510
The purpose of this study is to help us learn whether an additional dose of COVID-19 study vaccine with or without lowering an anti-rejection medicine can help transplant recipients make more antibody to COVID-19. This study will enroll kidney or liver recipients at least 12 months post-transplant who have received 2-4 doses of the Moderna or Pfizer COVID-19 vaccine at least 30 days ago.
Principal Investigator: Emily Blumberg, MD
Sponsor: NIH
Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007
The purpose of this study is to evaluate long-term outcomes in transplant recipients with HIV who receive kidneys from donors with HIV compared to donors without HIV.
Principal Investigator: Emily Blumberg, MD
Sponsor: Johns Hopkins University
Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007
The purpose of this study is to compare oral ibrexafungerp to the current standard antifungal treatment (oral fluconazole, oral voriconazole, or IV Caspofungin)
Principal Investigator: Emily Blumberg, MD
Sponsor: Scynexis
Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007
Principal Investigator: Ronald Parsons, MD
Sponsor: Hansa Biopharma AB
The purpose of this study is to demonstrate the efficacy and safety of imlifidase in comparison to the standard of care (SoC) in the management of highly sensitized transplant patients. If you decide to take part in this study, you will be randomly assigned (much like the flip of a coin) to treatment with either investigational imlifidase or SoC. SoC management means desensitization according to the standard treatment options available at the hospital or waiting for a more compatible organ offer.
Contact: Hercys Sanchez Rodriguez, Research Coordinator
Email: Hercys.SanchezRodriguez@pennmedicine.upenn.edu
Phone: 215-410-9378
Co-Principal Investigators: Ronald Parsons, MD
Sponsor: Regeneron Pharmaceuticals, Inc
The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA)
Contact: Hercys Sanchez Rodriguez
Email: Hercys.SanchezRodriguez@pennmedicine.upenn.edu
Phone: 215-410-9378
Co-Principal Investigators: Ronald Parsons, MD
Sponsor: Regeneron Pharmaceuticals, Inc
The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study
Contact: Hercys Sanchez Rodriguez
Email: Hercys.SanchezRodriguez@pennmedicine.upenn.edu
Phone: 215-410-9378
Principal Investigator: Roy Bloom, MD
Sponsor: Memo Therapeutics AG
The purpose of the study is to assess the efficacy and safety of AntiBKV in comparison to placebo in management of BK viremia. AntiBKV or placebo is administered intravenously every 4 weeks for a total of four doses.
Contact: Lindsay O’Rourke
Email: Lindsay.O’Rourke@pennmedicine.upenn.edu
Phone: 215-615-0773
Principal Investigator: Roy Bloom, MD
Sponsor: NIAID
The purpose of the study is to compare post-transplant standard of care treatment to subcutaneous abatacept. All participants will be observed for initial 6 months to assess if they should continue in observational study or be randomized 2:1 (abatacept: SOC) for remaining 18 months.
Contact: Lindsay O’Rourke
Email: Lindsay.O’Rourke@pennmedicine.upenn.edu
Phone: 215-615-0773