5 results
The primary objective of this study is to evaluate the efficacy of roxadustat compared todarbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)subjects.The secondary objectives of this study are to:*…
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)
To evaluate the diagnostic performance and safety of metal allergens proposed for inclusion in Metal Panel T.R.U.E. Test. The study will compare the diagnostic performance (primary) and safety (secondary) of ascending patch test doses of aluminum,…
The primary objective of this study is to investigate whether darbepoetin alfa is effective in reducing the incidence of late anemia in infants with HDN treated with IUT and therefore in decreasing the number of top-up transfusion required per…