A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS OF INTRAVENOUS ASCENDING DOSES OF IDES IN KIDNEY TRANSPLANTATION
Phase of Trial: Phase II
Latest Information Update: 03 Aug 2017
At a glance
- Drugs Imlifidase (Primary)
- Indications Renal transplant rejection
- Focus Adverse reactions
- Sponsors Hansa Medical AB
- 03 Aug 2017 Combined results of trials ( NCT02224820, NCT02426684, NCT02475551) assessing the efficacy of IdeS with regard to desensitization and transplantation of a kidney from an HLA-incompatible donor.published in the New England Journal of Medicine
- 02 Aug 2017 According to a Hansa Medical media release, combined results from this and 2 other trials (CT 230633 and 256416) have been published in the New England Journal of Medicine.
- 19 May 2017 According to a Hansa Medical media release, the European Medicines Agency (EMA) has granted access to its Priority Medicines (PRIME) scheme for IdeS. The PRIME designation for IdeS was granted on the basis of data from four independent Phase II studies in the US and Sweden (see CT profiles 269806, 230633, 244081 and 256416).