At a glance
ClinicalIndex Comparison Record- ✓Kidney transplant waitlist patient who has previously undergone unsuccessful desensitization or in whom effective desensitization will be highly unlikely due to breadth and strength of sensitization.
- ✓Have a live or deceased donor with a positive crossmatch test.
- ✕Previous treatment with IdeS.
- ✕Previous high-dose IVIG (2 g/kg BW) within 28 days prior to IdeS treatment.
- ✕HIV-positive.
- ✕Clinical signs of HBV or HCV infection.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Evaluate the Efficacy of IdeS (IgG Endopeptidase) to Desensitize Transplant Patients With a Positive Crossmatch Test
In Brief
A Phase 2 clinical trial evaluating IdeS and Kidney transplantation for Kidney Failure, Chronic. Completed, enrolled 19 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.
Study Details
Timeline
Interventions
One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.
Performed following IdeS treatment