Project LIFT: Lifestyle Intervention to promote Fitness in Transplantation

Principal Investigator: Peter Reese, MD, MSCE

Type Of Study: Pilot, Randomized Controlled Trial

Brief Description Of Study: Project LIFT is a remotely-monitored home exercise program that tests the use of wearable devices, financial incentives, and health questions to promote healthy behavior.

Detailed Study Description: Among kidney (KT) and liver transplant (LT) recipients, weight gain and obesity is associated with poor graft function. Yet, within a year of transplantation, habituation to a sedentary lifestyle, changes in metabolism, and immunosuppression drugs contribute to an average 4-10 kg weight gain for recipients. Recent innovations in wearable devices technology can passively monitor an individual’s physical activity.  Additionally, incentives and health questions designed using insights from behavioral economics have been shown to motivate device engagement and improvements in health behaviors. A remotely-monitored exercise program could improve behavior change and take advantage of the high motivation for improving health in this population.

General Inclusion Criteria: Adult liver or kidney transplant recipients within 2 – 24 months after of transplantation. They have to have a smartphone and be willing to receive text messages.

General Exclusion Criteria:

  1. Inability to provide informed consent; 
  2. Does not have daily access to a smartphone compatible with the wearable device
  3. Unable or unwilling to complete the baseline measurements and survey or return to perform the exit interview and weigh-in
  4. Already enrolled in an financial incentive-based exercise program using a wearable device
  5. Use of a wearable accelerometer or pedometer outside of the study protocol
  6. Any other medical conditions that would prohibit participation in a physical activity program
  7. Severe vision, hearing, or mobility impairment precluding participation

Contact Information:
Dr. Peter Reese
Principal Investigator
Peter.Reese@uphs.upenn.edu

Adam Mussel
Project Manager
Adam.Mussell@uphs.upenn.edu

Sakshum Chadha
Clinical Research Coordinator
Sakshum.Chadha@uphs.upenn.edu
215-746-0355

Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors (HCV)

Co-Principal Investigators: David Goldberg, MD, MSCE and Peter Reese, MD, MSCE

Sponsor: Merck

This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant wait list, who will then be treated with Zepatier after the single kidney transplantation.

Research coordinator: Anna Sicilia, anna.sicilia@uphs.upenn.edu

PERT Study: The Use of Peri-operative Intravenous Estrogen for the Mitigation of Ischemia Reperfusion Injury in the Setting of Renal Transplantation

Principal Investigator: Matthew Levine, MD, PhD

The purpose of this study is to see if giving intravenous (IV) estrogen at the time of kidney transplant will help the kidney work properly after it is transplanted. Sometimes after a kidney is transplanted, the kidney does not work as it should right away. When this happens, patients typically require dialysis treatments within the first week after transplant.

When the transplanted kidney does not work right away, there can be increased medical costs, increased length of hospital stay and decreased graft (kidney) survival. Currently there are no preventative measures or treatments though dialysis is used until recovery of kidney function occurs. Some research studies in mice have shown a more positive outcome in female compared to male mice. Research in this area has focused on hormonal effects of estrogen and testosterone. This is a randomized trial where participating subjects will receive either three doses of intravenous estrogen or an intravenous placebo during their hospital stay.

Contact: Mary Shaw, BBA, RN at 215-615-0528 or mary.shaw@uphs.upenn.edu

A Phase 2a, 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 Protocol for Phase 2a Study of Bleselumab (ASKP1240)

Principal Investigator: Simin Goral, MD,

Type Of Study: Randomized Open-Label Trial

Brief Description Of Study:  The Bleselumab study is a randomized study to assess the use of study drug Bleselumab or standard of care in preventing recurrence of FSGS in first time kidney transplant recipients.

Detailed Study Description:   This is A Phase 2a, 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 denovo Kidney Transplant Recipients.  Approximately 45 investigative centers in North America will plan to enroll 60 male and female subjects 18 years of age or older who are de novo, living or deceased donor kidney recipients and have biopsy-proven primary focal segmental glomerulosclerosis (pFSGS). 

General Inclusion Criteria: Adult de novo kidney transplant recipients from a living or deceased donor and has biopsy-proven, pFSGS as a cause of ESRD in their native kidneys (initial diagnosing biopsy report is required).  A subject who has biopsy-proven pFSGS as a cause of ESRD, and their most current graft failure(s) is due to biopsy-proven, recurrent FSGS, is eligible..

General Exclusion Criteria:

  1. Inability to provide informed consent;
  2. Diagnosis of secondary FSGS
  3. Subject has previously received any organ transplant including a kidney and the most currentgraft failure(s) is not due to the recurrence of FSGS.
  4. Subject will receive a kidney as part of a multi-organ transplant.
  5. Subject will receive a dual kidney transplant from a deceased donor.
  6. Subject will receive a kidney with an anticipated cold ischemia time of > 30 hours.
  7.  Subject will receive a kidney that meets BOTH Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. (A kidney that meets either ECD OR DCD criteria may be
    eligible for inclusion.)

Contact Information:

Dr. Simin Goral
Principal Investigator
simin.goral@uphs.upenn.edu

Jennifer Trofe-Clark, PharmD
Transplant Pharmacist
215-614-4274
Jennifer.trofe-clark@uphs.upenn.edu

Robin Neubauer, RN
Research Nurse
215-615-0773
Robin.neubauer@uphs.upenn.edu

A Multicenter, Prospective, Double-blind, Randomized, Placebo-Controlled, Phase 3 study of BB3 to reduce the severity of delayed graft function in recipients of a deceased donor kidney

Principal Investigator: Simin Goral, MD,

Type Of Study: Randomized Double-Blind Trial

Brief Description Of Study:  The purpose of this study is to evaluate the safety and efficacy of BB3 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after deceased donor renal transplant.

Detailed Study Description:   The study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg BB3 or placebo (normal saline). Study drug will be administered daily for a total of 3 infusions over a 30-minute period, with the first dose administered within 30 hours post-transplant and subsequent doses 24 hours (± 2 hours) after previous dose.

General Inclusion Criteria: The study will be conducted in recipients of a deceased donor de-novo renal allograft who are at high risk for delayed graft function (need for dialysis in the first 7 days post-transplant) and have early clinical indications of DGF based on poor renal function (no or low urine output) post-transplant.

General Exclusion Criteria:

  1. Inability to provide informed consent;
  2. Signs and symptoms of volume depletion
  3. Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
  4. Recipient of an ABO-incompatible kidney.
  5. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
  6. Recipient of a kidney preserved by normothermic PMP.
  7. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.

Contact Information:

Dr. Simin Goral
Principal Investigator
simin.goral@uphs.upenn.edu

Jennifer Trofe-Clark, PharmD
Transplant Pharmacist
215-614-4274
Jennifer.trofe-clark@uphs.upenn.edu

Robin Neubauer, RN
Research Nurse
215-615-0773
Robin.neubauer@uphs.upenn.edu

Evaluation of patient outcomes from the Kidney Allograft Outcomes Allosure Registry (KOAR)

Principal Investigator: Simin Goral, MD,

Type Of Study: Registry study

Brief Description Of Study:  This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry.

Detailed Study Description:   This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients from approximately 35 investigative centers enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers that do not perform protocol surveillance biopsies. This registry study does not provide any medical care. Outcomes in this sub-cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes of the test and control cohorts.   A matched control cohort of 300 patients will be retrospectively selected from the subset of centers providing the test cohort patients who have planned surveillance biopsies at 12 months post-transplantation.

General Inclusion Criteria: Medicare–covered renal transplant recipients selected by their providers to receive AlloSure testing as part of their practical care beginning by 2 months post-transplantation.

General Exclusion Criteria: Renal transplant recipients without Medicare coverage

Contact Information:

Dr. Simin Goral
Principal Investigator
simin.goral@uphs.upenn.edu

Jennifer Trofe-Clark, PharmD
Transplant Pharmacist
215-614-4274
Jennifer.trofe-clark@uphs.upenn.edu

Robin Neubauer, RN
Research Nurse
215-615-0773
Robin.neubauer@uphs.upenn.edu

Protocol MK-8228-002: 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: Emily Blumberg, MD, FACP, FIDSA, FAST

Sponsor: Merck

The main purpose of this study is to compare letermovir to valganciclovir in preventing CMV disease in adult subjects who are CMV seronegative and have received a kidney transplant from a CMV seropositive donor. In this study, patients will take letermovir (or placebo for letermovir) plus valganciclovir (or placebo for valganciclovir) for 28 weeks after kidney transplant, instead of receiving the standard of 6 months valganciclovir post-transplant. Patients who meet the study requirements will be put into a group by chance in order to decide if they will receive letermovir or valganciclovir.   Each person in the study will have a 50 percent chance of being assigned to receive letermovir or valganciclovir (i.e., for every 1 patient getting letermovir, 1 will get valganciclovir).  Neither the patients nor the patient’s care team will know whether the patients will receive letermovir or valganciclovir.  However, this information can be obtained if there is a medical emergency.

Contacts:

Dr. Emily Blumberg blumbere@pennmedicine.upenn.edu

Maryann Najdzinowicz, RN at maryann.najdzinowicz@uphs.upenn.edu

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