At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
IdeS® (Imlifidase)drug
Likely dose
IdeS® (Imlifidase) 0.24mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial to Evaluate the Safety and Tolerability of Ides® (IgG Endopeptidase) to Eliminate Donor Specific HLA Antibodies (DSAs) and Prevent Antibody-Mediated Rejection Post-Transplant in Highly-HLA Sensitized Patients.
In Brief
A Phase 2 clinical trial evaluating IdeS® (Imlifidase) for Renal Disease. Completed, enrolled 17 participants across 1 site.
Detailed 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®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Disease
CountriesUnited States
CollaboratorsHansa Biopharma AB
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionNov 2017
TodayJul 2026
First PostedApr 27, 2015
Enrollment StartJun 16, 2015
Primary CompletionNov 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.2 years ago
Interventions
IdeS® (Imlifidase)drug
0.24mg/kg IdeS