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Felzartamab in Late Antibody-Mediated Rejection

NCT05021484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-04-18

No results posted yet for this study

Summary

This prospective trial will assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and efficacy of the fully human CD38 monoclonal antibody felzartamab in kidney transplant recipients with late active or chronic-active ABMR. The study is designed as a randomized, controlled, double-blind pilot phase 2 trial. Participants will be randomized to receive either felzartamab or placebo for a period of six months, and then followed for another six months. After six and twelve months, study participants will be subjected to follow-up allograft biopsies.

Conditions

  • Antibody-mediated Rejection

Interventions

DRUG

Felzartamab

Intravenous infusion in regular intervals over 6 months

DRUG

Placebo

Intravenous infusion in regular intervals over 6 months

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Biogen

    collaborator INDUSTRY

  • Farsad Eskandary

    lead OTHER

Principal Investigators

  • Georg A Böhmig, MD · Department of Internal Medicine III, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2024-03-07
Completion
2024-03-07

Countries

  • Austria
  • Germany

Study Locations

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Entities

Drugs
Companies

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 NCT05021484 on ClinicalTrials.gov