Clinical Trial Details
| Trial ID: | L1297 |
| Source ID: | NCT03507348 |
| Associated Drug: | Visits Of Tocilizumab Injection (Every 4 Weeks, Up To 5 Visits) |
| Title: | Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | End-stage Renal Disease|Kidney Transplantation|Hla-incompatible Kidney Transplant Candidates |
| Interventions: | DRUG: visits of tocilizumab injection (every 4 weeks, up to 5 visits)|DRUG: Rituximab 375 mg/m2 at Day-30|DRUG: Rituximab 375 mg/m2 at Day-15 (only for donors living)|OTHER: Transplant Day-0 |
| Outcome Measures: | Primary: Description of the results of the strategy of desensitization in patients who will access to kidney transplantation from deceased or living donors., Decrease of MFI for highest donor-specific alloantibody (DSA) between start and end of desensitization for every patient in each category, at day 1 start of desensitization, at day 0 of Graft | Secondary: Desensitization efficacy with regards to DSA decrease and kidney transplantation, MFI for highest DSAs for each group, Day-198, at day-30 Graft, at day-15, at day0 of Graft,|impairment of DSA synthesis, Decrease in peripheral plasma cells and plasmablasts of \>50%, Day-198, at day-30 Graft, at day-15, at day0 of Graft,|Impairment of immune response, Decrease in complement factors of \>25%, Day-198, at day-30 Graft, at day-15, at day0 of Graft,|Incidence of treatment desensitization protocols, emergent adverse events (safety and Tolerability), Emergent adverse events to the desensitization therapy will be carefully monitored during the treatment period and within the following three months., Day-198, at day-30 Graft, at day-15 |
| Sponsor/Collaborators: | Sponsor: University Hospital, Grenoble |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 8 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2018-07-01 |
| Completion Date: | 2019-11-21 |
| Results First Posted: | |
| Last Update Posted: | 2020-03-30 |
| Locations: | Grenoble Alpes University Hospital, La Tronche, France |
| URL: | https://clinicaltrials.gov/show/NCT03507348 |
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