Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients
NCT Number: NCT06461546
Acronym: LIVEDES
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Kidney Transplant Candidates
Interventions: DRUG: Imlifidase
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2026-12

Summary:
This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft.

Primary Outcome Measures: • Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses)., The fraction of patients with a conversion of a positive FC-XM within 6 hours of treatment with imlifidase., 6 hours
Secondary Outcome Measures: 1. Proportion of patients that require a second dose of imlifidase, To evaluate flow cytometry T-cell crossmatch conversion within 24 hours of imlifidase treatment, requirement of a second dose of imlifidase., 24 hours|2. To evaluate the rebound of preexisting donor specific antibodies (DSA) (difference between MFI of each DSA daily - until D+14 - compared to pre-imlifidase administration), Pre-existing DSA appearance measured daily until D+14, daily, from day 0 to day 14|3. De novo DSA appearance over 14 days after imlifidase treatment, To evaluate the appearance of de novo DSAs (any DSA no present in pre-transplant or historical) daily - until D+14. To be considered positive the bead MFI should be over 750 and to be above the bead specific threshold related to the lowest bead of the same locus., daily, from day 0 to day 14|4. To evaluate HLA/DSA antibody levels up to 1 year after transplantation, HLA/DSA antibody levels at several time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment, time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment|5. To evaluate renal function up to 1 year after transplantation, by estimated glomerular filtration rate (eGFR) and serum/plasma creatinine levels, time points between 24 hours and 2 weeks and at 1, 3 and 6 months and 1 year after transplantation as assessed|6. To evaluate patient survival 1 year after transplantation, Patient survival at 12 months after transplantation, at 12 months after transplantation|7. To evaluate the graft survival at 12 months, To evaluate the graft survival at 12 months (both overall and death-censored analysis)., at 12 months after transplantation|8. Proportion of patients with biopsy confirmed rejection, either cell-mediated or antibody-mediated rejection, over 1 year, To evaluate the incidence of acute allograft rejection within 12 months (overall and stratified by type: cell mediated rejection or antibody-mediated rejection, within 12 months|9. To evaluate safety of Imlifidase treatment with regards to infusion related reactions occurring within 48 hours of Imlifidase infusion, Proportion of patients with infusion-related reactions within 48 hours of Imlifidase infusion, within 48 hours of Imlifidase infusion|10.adverse events within 30 days after transplantation, Proportion of patients with adverse events within 30 days after transplantation, 30 days after transplantation|11. Proportion of patients with severe or serious infections, To evaluate the adverse events ( infectious disease that required hospitalization) at 6 and 12 months., 6 months and 12 months|12. To evaluate safety of Imlifidase treatment with regards to reported serious adverse events (SAEs), Safety over 1 year as measured by reported SAEs, 12 months