Clinical Trials Group

The research division of the Kidney Transplant Program began in 1992 with one coordinator. Currently, seven staff are coordinating 17 studies related to either kidney transplantation or nephrology. The Clinical Trials Group has participated in many research studies that subsequently led to approval by the FDA and HPB. As a result, more drugs are now available to help prevent organ rejection, including Neoral, CellCept, Zenapax, and Sirolimus.

Recipients are offered the opportunity to particpate in clinical studies at the time of their transplant. These new drugs, used in different combinations with current anti-rejection drugs, have reduced rejection rate and side effects. We obtain data and information about our study patients for as long as five years. Many patients feel they received additional, valuable care while in the study which is beneficial to their total well-being.

Goals of the Clinical Trials Group:

• Provide treatments that improve the quality of life
• Provide medications with fewer side effects
• Compare investigational drugs to existing treatments
• Provide medications that allow shorter periods of treatment

Some current studies include:

•  A placebo-controlled, double-blind study of the effect of two dose levels of sirolimus plus standard immunosuppressive therapy in renal allograft recipients (Principal investigator: Dr. A.S. MacDonald)
• An open label extension study of the safety of long-term administration of sirolimus (Rapamune) in renal allograft recipients (Principal investigator: Dr. A.S. MacDonald)
• A prospective evaluation of tacrolimus-based immunosuppressive therapy in highly-sensitized renal allograft recipients (Principal investigator: Dr. V. McAlister)
• A randomized comparative trial of Prograf (tacrolimus, FK506) in combination with azathioprine or mycophenolate mofetil vs. Neoral with mycophenolate mofetil after cadaveric kidney transplantation (Principal investigator: Dr. V. McAlister)
• A randomized open label study of continuous therapy with cyclosporine and sirolimus followed by continuous therapy with sirolimus in renal allograft recipients (Principal investigator: Dr. J. Lawen)
• A three year, randomized, multicenter, double-blind, double-dummy, parallel group study of the efficacy and safety of SDZ RAD tablets versus mycophenolate mofetil as part of triple immunosuppressive therapy in de novo renal transplant recipients. (Principal investigator: Dr. J. Lawen)
• Prograf as secondary intervention vs. continuation of cyclosporine in patients at risk for chronic renal allograft failure. (Principal investigator: Dr. J. Lawen)
• A dose finding and dose scheduling study of Novel Erythropoiesis Stimulating Protein (NESO) administered by intravenous bolus in patients with end stage renal disease receiving hemodialysis. (Principal investigator: Dr. K. Jindal)
• A double-blind, placebo-controlled, randomized trial of low-intensity adjusted-dose warfarin for the prevention of mechanical malfunction of double-lumen hemodialysis. (Principal investigator: Dr. C. Clase)
• How symptomatic are patients with chronic kidney disease when they start dialysis? (Principal investigator: Dr. C. Clase)
• When should patients with chronic kidney failure start dialysis? (Principal investigator: Dr. C. Clase)
   

Last Updated: 7/27/2010 9:58:31 AM