beeldscherm schreef op 18 mei 2018 11:26:
FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients
www.raps.org/news-articles/news-artic.....
According FDA, sponsors should conduct two randomized placebo-controlled Phase III superiority studies to demonstrate effectiveness if the drug they are testing isn't approved for any other indications, though the agency says that a single Phase III study in combination with other evidence study may be sufficient if the drug has already gone through trials in a closely related indication or if the results of efficacy in a single trial are "highly robust."
FDA also says the study protocol should specify the type of donors (i.e., donation after brain death, donor after cardiac death or living donor) that will be used, as well as the type of organ recovery, storage, transport conditions and post-transplantation immunosuppressive therapy.
In addition, FDA says that sponsors should plan on building a preapproval safety database of at least 300 patients, but says that a smaller database may be appropriate "depending on the benefit demonstrated."
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In the study, Dr. Luis Fernandez of the University of Wisconsin used a non-human primate model to evaluate the outcomes of kidney transplantation from brain dead donors. Kidneys that were treated with rhC1INH prior to transplantation had a significantly lower incidence of delayed graft function (DGF) when transplanted to the recipient animal s. Dr. Fernandez and colleagues were also able to show how rhC1INH inhibited the complement cascade to confer this benefit.
www.drugs.com/clinical_trials/pharmin...