Research and Clinical Trials

Tampa General Medical Group physicians are actively involved in multiple clinical trials. The following is a list of trials that are currently enrolling patients.

STUDIES INVESTIGATING RENAL DISEASE

Transform

A 24-month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs. mycophenolate with standard calcineurin inhibitor in de novo renal transplantation – advancing renal transplant efficacy and safety outcomes with an everolimus-based regmen.

Primary Investigator: Dr. John Leone

Coordinator: Debbie Fernandez, (813) 844-5692

Protect

A prospective observational trial to evaluate the correlation of T-SPOT® response to CMV infection and T cell-mediated acute graft rejection.

The study is a non-interventional observational study to evaluate T-cell responses in kidney transplant recipients to: (a) CMV-specific antigens (T-SPOT.CMV), and (b) a reference panel of donor cells as a marker for acute rejection (T-SPOT. SPOT.PRT)

Primary Investigator: Dr. Raj Baliga
Coordinator: Debbie Fernandez, (813) 844-5692

Immunosuppression

Evaluating Nulojix (belatacept) long-term safety in transplant enlist registry

Primary Investigator: Dr. Victor Bowers
Coordinator: Debbie Fernandez, (813) 844-5692

Belatacept for Renal Transplant

Evaluation of the benefits and risks in maintenance renal transplant recipients following conversion to Nulojix® (belatacept) - based immunosuppression.

Primary Investigator: Dr. Victor Bowers
Coordinator: Debbie Fernandez, (813) 844-5692

Monoclonal Antibody

A three-part, multicenter, randomized, double-blind, placebo-controlled parallel group, sequential adaptive, phase II study to evaluate the safety, tolerability and efficacy of OPN-305, a humanized monoclonal antibody that blocks toll-like receptor 2, in renal transplant patients at high risk of delayed graft function.

Primary Investigator: Dr. Victor Bowers
Coordinator: Debbie Fernandez, (813) 844-5692

Belatacept for Renal Transplant (at time of transplant)

To determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant recipients. 

Primary Investigator: Dr. John Leone and Dr. Tambi Jarmi
Coordinator: Debbie Fernandez, (813) 844-5692 

Prevention of Delayed Graft Function

A randomized, parallel-group, double-blind placebo-controlled, multi-center study of eculizumab for the prevention of delayed graft function after kidney transplantation in adult subjects at increased risk of delayed graft function. 

Primary Investigator: Dr. Rajendra Baliga
Coordinator: Debbie Fernandez, (813) 844-5692 

STUDIES INVESTIGATING HEPATOCELLULAR CARCINOMA (HCC)

Lenvatinib vs. Sorafenib
A multicenter, randomized, open-label, phase 3 trial to compare the efficacy 
and safety of Lenvatinib versus Sorafenib in first-line treatment of subjects with unresectable hepatocellular carcinoma.

Primary Investigator: Dr. Angel Alsina 
Coordinator: Mirjam Zuske, (813) 844-5691

Regorafenib after Sorafenib
A randomized, double blind, placebo-controlled, multicenter phase III
study of Regorafenib in patients with hepatocellular carcinoma (HCC) after Sorafenib.

Primary Investigator: Dr. Angel Alsina
Coordinator: Mirjam Zuske, (813) 844-5691

Sorafenib Post-liver Transplant

A randomized, placebo-controlled, blinded, multicenter phase II study of Sorafenib adjuvant therapy in high risk orthotopic liver transplant (OLT) recipients with hepatocellular carcinoma (HCC).

Primary Investigator: Dr. Angel Alsina
Coordinator: Mirjam Zuske, (813) 844-5691