NCT06461546

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients (LIVEDES)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The patients between 18 and 65 years will be flow cytometry crossmatch (FC-XM) positive against an available living donor. The imlifidase treatment will turn the crossmatch test negative prior to transplantation. A second dose of imlifidase can be given within 24 hours if the first dose is considered not to have sufficient effect. If a second dose is given, a confirmatory FCXM test will be performed pre-second imlifidase dosing and between 2-6 hours following the second dose.

Conditions

• Kidney Transplant Candidates

Interventions

Type	Name	Description
DRUG	Imlifidase	* Imlifidase (POD0, pre-transplantation), imlifidase, 0.25 mg/kg over a period of 15 minutes, prior to transplantation. * Dose Adjustment Criteria FC-XM screening and single antigen will be performed after 6 hours of imlifidase infusion, It will take 3 hours to obtain the results, respectively: * NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible. * POSITIVE (FC-XM) - 2nd Imlifidase infusion will be required (imlifidase dose: 0.25mg/Kg). FC-XM screening and single antigen will be performed after 2 hours of the 2nd Imlifidase infusion: * NEGATIVE (FC-XM) - renal transplantation will be performed as soon as possible. * POSITIVE (FC-XM) - The scheduled kidney transplant will be canceled.

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2024-06-17
• Last updated: 2025-03-12