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An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

NCT04711850 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2025-05-28

Study results available
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Summary

The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.

Conditions

  • Kidney Transplant Rejection

Interventions

DRUG

Imlifidase

Immunoglobulin G degrading enzyme of Streptococcus pyogenes

Sponsors & Collaborators

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Hansa Biopharma AB

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-03-30
Completion
2023-03-30
FDA Drug
Yes

Countries

  • Austria
  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT04711850 on ClinicalTrials.gov