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Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

NCT06461546 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

  • Kidney Transplant Candidates

Interventions

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.

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Fritz Diekmann, Dr · Fundació de Recerca Clínic Barcelona - Institut D'Investigacions Biomèdiques Agustí Pí i Sunyer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2026-12-31
Completion
2027-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06461546 on ClinicalTrials.gov