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Trial to Test Branded vs. Generic Anti-Rejection Drugs

Rita Alloway (University of Cincinnati)

Rita Alloway (University of Cincinnati)

Researchers at University of Cincinnati will lead a clinical trial testing a brand-name drug to reduce rejection of transplants against generic versions. The $2.7 million study, funded by the Food and Drug Administration, includes colleagues from University of Colorado and Cincinnati Children’s Hospital Medical Center.

The trial will test the drug tacrolimus, an immunosuppressant compound marketed under the trade name Prograf by Astrellas Pharma, against two generic versions with liver and kidney transplant patients. Tacrolimus is given to patients after transplants to reduce the activity of the patient’s immune system and lower the risk of rejection.

The drug works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ. As a result the dosage level needs to be carefully calibrated to maximize its effectiveness without causing adverse side effects.

Rita Alloway, a professor of medicine at Cincinnati and principal investigator on the study (pictured left), elaborates saying “Too high exposure to these drugs increases the risk of toxicity, over-immunosuppression, and cancer in patents. Too low exposure may lead to rejection of the organ by the patient’s immune system.”

Because of these concerns, some transplant physicians and their patients are wary of generic versions of the drug, particularly that the quality and therapeutic efficacy of the generics may differ from the branded product. The study will test these concerns in a prospective, blinded, six-way crossover study in stable kidney and liver transplant patients.

The trial will involve two of the most disparate generic versions of tacrolimus, on whether their potency, purity, and concentrations are biologically equivalent to the branded version. “Currently more than 50 percent of transplant patients are dispensed generic tacrolimus,” notes Alloway. “We’re investigating whether even the most disparate generics have the same efficacy in healthy post-transplant patients.”

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