Anil Paramesh, M.D. – Principal Investigator

Professor of Surgery, Urology and Pediatrics
William Henderson IV Endowed Chair in Surgery
Surgical Director of Kidney/Pancreas/Living Donor Transplantation

Active Trials

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

  • Sponsor: CareDX
  • Description: This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients 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 the 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. The primary endpoint of this study is interstitial fibrosis/tubular atrophy (IF/TA) at one-year post-transplant, quantified by biopsy-based histopathology grade(s). The primary efficacy endpoint is the number of renal allograft biopsies performed during the first year.

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

  • Sponsor: The National Institutes of Health (NIH)
  • Description: This study is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry. Patients will be asked to provide blood and urine once at one study visit, but the study plans to follow the patient’s health information for at least 10 years using data from the patient’s transplant program and from a national kidney transplant registry.

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

  • Sponsor: CSL Behring
  • Description: The purpose of this research study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance) in kidney transplant recipients with CABMR. The study will test whether or not clazakizumab can slow or prevent the decline in the working of the transplanted kidney and lengthen the time before patient will need to go back on dialysis or get a new kidney. Clazakizumab or placebo will be given subcutaneously once every 4 weeks, for up to 5 years.

Upcoming Trials

BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

  • Sponsor: Eledon Pharmaceuticals
  • Description: This is a randomized, multicenter, open-label, active control study to assess the safety and efficacy of tegoprubart compared to tacrolimus in the preservation of allograft function in kidney transplant patients. This study will last approximately 12 months with the option of a 12-month extension study.

 

 

 

Mohd Sharshir, M.D. – Principal Investigator

Transplant Nephrologist
Medical Director of the Kidney Transplant and Living Donor Program

Active Trials

TruGraf™ Long-term Clinical Outcomes Study (TRULO STUDY)

  • Sponsor: Transplant Genomics
  • Description: This is a prospective, multi-center, observational study. The study objective is to evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf™ and TRAC™ monitoring. Subjects will have TruGraf™ and TRAC™ testing at study enrollment and thereafter every 3 months. Data collection for the primary objective extends over a 2-year period.

 

 

 

Hoonbae Jeon, M.D. – Principal Investigator

Transplant and Hepatobiliary Surgeon
Section Chief of Abdominal Transplant

Active Trials

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

  • Sponsor: CareDX
  • Description: This is a multi-center observational cohort study assessing LiverCare in managing liver transplant recipients. This is a pilot study to examine the feasibility and safety of the protocol in preparation for a larger clinical trial. The primary objective of this study is to correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibodies (DSA). LiverCare is anticipated to be made up of 6 components that will be included in this study: AlloSure Liver, AlloMap Liver, AlloHeme Liver, iBox Liver, HistoMap Liver, and AlloID. LiverCare will be collected at the time of all histologic analyses whether ‘for cause’ or ‘surveillance’. This study will last approximately 3 years post-transplant.

 

 

 

Arnold Alper, M.D. – Principal Investigator

Transplant Nephrologist

Active Trials

Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)

  • Sponsor: AlloVir
  • Description: This is a follow-up study for patients who were previously enrolled in Posoleucal clinical trials. The purpose of the study is to determine the effectiveness of the drug posoleucel (ALVR105) or a placebo over time on kidney function. This study will last approximately 3.5 years.

 

 

 

Fredric Regenstein, M.D. – Principal Investigator

Professor of Clinical Medicine
Medical Director of Liver Transplantation

Active Trials

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis – The REVERSE Study

  • Sponsor: Intercept      
  • Description: The purpose of this study is to find out how safe and effective obeticholic acid (OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several regions in North America and Europe for the treatment of another form of chronic liver disease called Primary Biliary Cholangitis (PBC). It has not been approved to treat cirrhosis as the result of NASH. This study has two parts. Double-blind treatment phase for 12 months and optional Open-Label Extension phase for 12 months. In the double-blind treatment phase, patients will receive OCA or placebo and neither the doctor or patient will know which one the patient is taking. In the open label extension phase all patients will receive OCA and the purpose is to learn about the long-term safety effects of OCA in patients with compensated cirrhosis and NASH. Patients will be asked to consent to this optionally at the end of the double-blind treatment phase. Patients are expected to be in the study for approximately 2 years in total.

TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

  • Sponsor: Calliditas
  • Description: The Main Part of this study will be a randomized, placebo-controlled, double-blind, parallel-group, multicenter, adaptive Phase 2b/3 trial assessing oral setanaxib administered as an add-on therapy in patients with early PBC, elevated liver stiffness, and intolerance or inadequate response to UDCA. The safety and efficacy of 1200 mg/day and 1600 mg/day setanaxib will be assessed against matching placebo over up to 52 weeks of treatment. The safety and efficacy of setanaxib will be further assessed during a 52-week Extension Phase.

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis – The REGENERATE Study

  • Sponsor: Intercept
  • Description: The purpose of this study is to evaluate the effect of OCA compared to placebo on histological improvement in nonalcoholic Steatohepatitis (NASH) by assessing the following primary endpoints using NASH Clinical Research Network (CRN) scoring: improvement in fibrosis by at least 1 stage with no worsening of NASH, or resolution of NASH with no worsening of fibrosis. The study is event driven and total duration will be determined by the time required to accrue approximately 291 adjudicated events for the clinical outcomes composite endpoint, in the OCA 25mg and placebo groups combined, for subjects with fibrosis stage 2 and stage 3, estimated to take approximately 10 years.

A Longitudinal Observational Study of Patients with Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

  • Sponsor: Target PharmaSolutions
  • Description: A 5-Year, Longitudinal, Observational Study of Patients with Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatits designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

A Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma

  • Sponsor: Target PharmaSolutions
  • Description: A 5 year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.

 

 

 

Upcoming Trials

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOES)

  • Sponsor: Madrigal Pharmaceuticals
  • Description: A Phase 3, randomized double-blind placebo controlled study to evaluate the effect of Resmetirom on liver-related outcomes in patients with Well-compensated Non-alcoholic Cirrhosis (NASH). The patient will be taking either 60, 80, or 100 mg of Resmetirom or matching placebo once-daily. The study will last approximately 3 years.