Renal Transplantation at The University of Texas | Memorial Hermann -TMC

Research

The transplant team has played a vital role in the development of more effective immunosuppressive agents. The team was the first to administer rapamycin to man in clinical trials of the drug in human renal transplantation and subsequently document drug synergy in man.

Groundbreaking studies

Neoral (cyclosporine)

Molecular structure of cyclosporine The major advance in immunosuppression in the past three decades has been the development of pharmacologic agents that inhibit T cells relatively selectively, the prototype of which is cyclosporine (CsA). Neoral, a newer formulation of cyclosporine, is more rapidly and completely absorbed than either the conventional olive oil liquid or gelcap formulation of CsA.

In 1980, The University of Texas Medical School at Houston is one of only three centers in the United States to test cyclosporine, and Ida Bradel is the first patient at the Center to be treated with this promising new immunosuppressant. Since that time, it has been shown that cyclosporine, now the cornerstone of most immunosuppressive regimens, increases graft survival rates at the end of the first year more than compared with the rate achieved with azathioprine therapy.

The Texas Kidney Institute opens in 1982 on the ninth floor of the Jones Pavilion in Memorial Hermann Hospital - TMC. This comprehensive patient care facility, the first such f acility for kidney patients in Houston, includes 53 beds, 12 dialysis units, and a staff experienced in treating patients of all ages with both chronic kidney diseases and acute kidney injuries. The institute's efforts are geared toward returning kidney disease patients to productive lives.

Rapamycin (sirolimus)

Molecular structure of rapamycin First, preclinical testing of a new drug candidate is conducted in animals and laboratory simulated scenarios to determine its base effectiveness. This research on rapamycin was performed at our Center from 1989 to 1992. Next, Phase I clinical trials are used to examine the safety of the drug in humans and to
determine the most appropriate dose levels. This research on rapamycin was performed at our Center in 1992. Phase II trials are then conducted to study the effectiveness of the drug for its intended purpose. This research on rapamycin was performed at our Center beginning in November, 1993. International Phase II trials of rapamycin began in July, 1994. Finally, Phase III trials study the safety and effectiveness of the drug compared with approved drug regimens in large numbers of patients in double-blinded studies. These studies began on rapamycin in 1996 with the 12-month data completed in 1998.

Current and upcoming studies

Myfortic / Simulect

A 12 month, multi-center, prospective open-label, randomized, parallel-group study to compare the efficacy and safety of an initially intensified dosing regimen of Myfortic and induction with Simulect vs. a standard dosing regimen of Myfortic and induction with antithymocyte globulin, in combination with tacrolimus and corticosteroids in de novo renal transplant recipients at high immunological risk.

Everolimus

A 12 month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing concentration-controlled Everolimus with low dose tacrolimus to Myfortic with standard dose tacrolimus in de novo renal transplant recipient.

Tacrolimus / Myfortic

A partially blinded, prospective, randomized, multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus, vs. myfortic plus tacrolimus in de novo renal transplant recipients.