drugset / Trial / NCT02426684

Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

NCT02426684

NaSingle-groupOpen-labelTreatment

Summary

This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and flow cytometry (FCMX) crossmatch + at time of transplant. We plan to enroll a total of 20 patients. Patients will be followed for 6 months post administration of IdeS®.

Timeline

Start
2015-06-16
Primary completion
2017-11-10
Completion
2017-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Imlifidase Protein / enzyme biologic 0.24 mg/kg

Indications