Active Clinical Trials Unit

Clinical trials are an important part of the abdominal transplant program at UAB.  These trials involve the integrated efforts of surgeons, nephrologists, and/or hepatologists, working with a dedicated cadre of research coordinators and support staff.  Charged with oversight of research protocols is Dr. Roslyn B. Mannon, in the Division of Nephrology.  Active studies include:

Belatacept evaluation of nephroprotection and efficacy as first line immunosuppression trial EXTended criteria donor-the purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Primary Investigator-Robert Gaston, MD

Sponsor-Bristol Myers Squib

Cidofovir in Renal Transplant Recipients with BKVN-the objectives of this study are to evaluate the safety and tolerability of 3 dose levels of cidofovir in renal transplant recipients with BK polyomavirus nephropathy.

Primary investigator-Clifton Kew, MD

Sponsor-National Institutes of Health/NIAID

Cinacalcet HCI - A prospective cohort study-this study investigates metabolic bone disease after kidney transplantation in those with elevated parathyroid hormone levels.

Primary Investigator-Roslyn Mannon, MD

Co-investigator-Hasan Khamash, MD

Sponsor-Amgen

Clinical Trials in Organ Transplantation: Optimization of Belatacept-this is a multicenter trial sponsored that is evaluating a number of protocols to optimize the use of Belatacept in kidney transplant patients with supportive mechanistic studies evaluating renal function and viral immunity.

Primary Investigator-Roslyn Mannon, MD

Co investigators-Drs. Devin Eckhoff, Robert Gaston, Jeremy Goodman, Michael Hanaway, Mary Prendergast

Sponsor-National Institutes of Health/National Institute of Allergy, Immunology and Infectious Diseases

Clinical Trials in Transplantation:  Rituximab in Kidney Transplantation-the objective of this multi-center study is to evaluate the effectiveness of rituximab therapy in preventing chronic injury after kidney transplantation.

Primary Investigator-Vineeta Kumar, MD

Co-investigator-Robert Gaston, MD

Sponsor-National Institutes of Health/NIAID

DeKAF - Long term deterioration of kidney allograft function-the objective of this multi-center study is to

define, in kidney grafts with early signs of functional failure, the clinical and pathological characteristics of allograft failure and loss.

Primary Investigator-Robert Gaston, MD

Co-investigator-Roslyn Mannon, MD

Sponsor-National Institutes of Health/NIAID

Genomics of Kidney Transplantation-this multicenter study is a companion study to DeKAF and designed to analyze the genetic predictors of kidney transplant function, failure, and immunosuppression metabolism.

Primary Investigator-Roslyn Mannon, MD

Co-investigator-Robert Gaston, MD

Quark - A dose escalation safety study of 15NP to prevent delayed graft function in patients undergoing deceased donor kidney transplantation-this study will test the safety of 15NP, a small interfering RNA, and measure how long the drug stays in the blood stream after injection in recipients at risk for delayed graft function.

Primary Investigator-Jeremy Goodman, MD

Co-investigator-Roslyn Mannon, MD

Sponsor-Quark Pharmaceuticals

RELIVE - Live kidney donor study/renal function study-this multicenter observational study will evaluate renal function and outcome of living kidney donors.

Primary Investigator-Clifton Kew, MD

Sponsor-National Institutes of Health/NIDDK

A facilitated access program to provide Everolimus (RAD) for maintenance patients completing therapy in RAD trails in solid organ transplantation-this study will facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials and to provide everolimus maintenance therapy through this access program and to collect and review safety data until drug is commercially available or the project has been discontinued.

Primary Investigator-Clifton Kew, MD

Sponsor-Novartis

Tamiflu 20234 A study of Tamiflu for treatment of influenza in immunocompromised patients-an investigation into management of influenza infection following transplantation

Primary investigator-Robert Gaston, MD

Sponsor-Genentech

EMMES Collaborative Islet Transplant Registry CITR - Islet cell transplants are an experimental alternative to pancreas transplantation for patients with severe hypoglycemia. The islet transplant procedure uses insulin-producing cells taken from a donor pancreas by a complex process of extraction and purification.  The resulting islet cells are placed into the liver's portal vein, where they produce insulin in response to meals and blood glucose levels as in a non-diabetic person. This multicenter registry collects data from patients who have received an islet cell transplant.

Primary Investigator - Devin Eckhoff, MD

Co-investigator - John Christien, MD

Sponsor - National Institute of Diabetes & Digestive & Kidney Diseases

Tamiflu IV - a multi-center trial to evaluate the safety of two dose levels of oseltamivir administered by intravenous infusion in the treatment of influenza.

Primary Investigator - Devin Eckhoff, MD

Co-investigators - Derek Dubay,MD & Steve Bynon, MD

Sponsor - F. Hoffmann-La Roche

New trials are added regularly. For more information about trial participation, please contact the Transplant Clinical Research office at 205-975-7583.