WithdrawnPhase 2

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

Stopped: Inability to provide study drug to participants

0Started 2024-10-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Known contraindications for therapy with IVIG, Rituximab, plasma exchange (PLEX) or Imlifidase.
✕. Recipients of Deceased Donors (DBD, Extended Criteria Donors (ECD) or DCD).
✕. A positive Complement-Dependent Cytotoxicity (CDC) Crossmatch against the living donor.
✕. HIV-positive subjects.
✕. Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
✕. Subjects with active TB.
✕. Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material.
✕. Subjects who have received or for whom multiple organ transplants are planned.

What they're measuring

• Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses).

Timeframe: 6 hours

Trial details

NCT IDNCT06461546

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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