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research

Clinical Trials

Clinical trials are research studies that test new treatments or procedures, including new treatment drugs, surgical techniques, gene therapy, or combinations of treatments and procedures.  Such trials may include: (1) "Prevention" trials to test ways that may lower the risk of disease; (2) "Screening" trials to test ways to find a disease in its early stages when it is most treatable; and (3) "Quality of Life" trials to find ways to improve the comfort and quality of life for patients with difficult or untreatable diseases.

The UC Department of Surgery has extensive experience in conducting clinical trials and takes part in many national multicenter studies to improve the treatment and quality of life for our patients.  We offer Phase I, Phase II and Phase III trials.  Phase I trials are preliminary studies involving a small number of patients to test the proper method of drug delivery or surgical procedure; Phase II trials continue these studies by testing the safety and effectiveness of the drug or procedure; and Phase III trials study how the new drug or procedure compares to the current standard of treatment.

Current Trials:
 
Division: Transplant

An open label randomized, single multicenter study to evaluate the efficacy and safety of early calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on mycophenolate mofetil; MMF(Cellcept®) and sirolimus (Rapamune®)
Sponsor: Investigator Initiated /Roche
PI: E. Steve Woodle, MD
Contact Email Phone
Rita Alloway, PharmD, BCPS, FCCP rita.alloway@uc.edu 513-558-1568
Accepting new patients? No
 
 
Division: Transplant

A Randomized, Controlled, Multi-center, Study fo Thymoglobulin Induction Therapy with a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients
Sponsor: Genzyme Corporation
PI: Steven Rudich, MD, PhD
Contact Email Phone
Rita Alloway, PharmD, BCPS, FCCP rita.alloway@uc.edu 513-558-1568
Accepting new patients? No
 
 
Division: Transplant

A Phase IIIb, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® vs. Modified Release Tacrolimus (MR) with CellCept® and Steroid Withdrawal in de novo Liver Transplant Recipients
Sponsor: Astellas
PI: E. Steve Woodle, MD
Contact Email Phone
Rita Alloway, PharmD, BCPS, FCCP rita.alloway@uc.edu 513-558-1568
Accepting new patients? No
 
 
Division: Transplant

A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Fiinding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 versus Tacrolimus in Combination with mMyfortic®, Simulect® and corticosteroids in de novo Adult Renal Transplant Recipients
Sponsor: Novartis
PI: E. Steve Woodle, MD
Contact Email Phone
Rita Alloway, PharmD, BCPS, FCCP rita.alloway@uc.edu 513-558-1568
Accepting new patients? Yes
 
 
Division: Transplant

A Randomized, Open-Label, Multicenter, Parallel-Group Study of Belatacept-Based Corticosteroid-Free Regimens in Renal Transplant
Sponsor: Bristol-Myers Squibb
PI: E. Steve Woodle, MD
Contact Email Phone
Rita Alloway, PharmD, BCPS, FCCP rita.alloway@uc.edu 513-558-1568
Accepting new patients? Yes
 
 
Division: Urology

A Randomized, Double-Blind Phase III Study to Evaluate Adjuvant cG250 Treatment versus Placebo in Patients with Clear Cell RCC and High Risk of Recurrance
Sponsor: Wilex AG
PI: R. Bruce Bracken, MD
Contact Email Phone
Barb Burke burkeb@ucmail.uc.edu 513-558-4060
Accepting new patients? Yes
 
 
Division: Urology

Study of Urethral Coated with Eluting Silver Salts (SUCCESS)
Sponsor: C.R. Bard, Inc.
PI: R. Bruce Bracken, MD
Contact Email Phone
Barb Burke burkeb@ucmail.uc.edu 513-558-4060
Accepting new patients? Yes
 
 
Division: Urology

A Randomized, Open-Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy
Sponsor: Sanofi-Aventis Encourium Group, Inc.
PI: R. Bruce Bracken, MD
Contact Email Phone
Barb Burke burkeb@ucmail.uc.edu 513-558-4060
Accepting new patients? Yes