A study aiming to collect data and provide a better understanding of the long-term outcome of imlifidase in treatment of immunological graft rejection in kidney transplant patients

A prospective, observational long-term follow-up trial of kidney transplant patients treated with imlifidase or plasma exchange after an active/chronic active Antibody-Mediated Rejection episode

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004777-49-AT

Enrollment

Registered

2020-12-17

Start date

2021-02-26

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated rejection in kidney transplant patients MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: Idefirix Product Name: Imlifidase Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Imlifidase CAS Number: 1947415-68-0 Other descriptive name: IML

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed Informed Consent obtained before any trial-related procedures • Willingness and ability to comply with the protocol • Previous treatment with imlifidase or plasma exchange in trial 16-HMedIdeS-12 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Inability by the judgement of the investigator to participate in the trial for any other reason

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to evaluate kidney graft survival in subjects that have been treated with imlifidase or plasma exchange in association with AMR in trial 16-HMedIdeS-12 (referred to as the feeder trial).;Secondary Objective: • Evaluate overall graft survival at Year 1 and 2 • Evaluate patient survival at Year 3 • Evaluate kidney function at Year 1, 2 and 3 • Evaluate DSA levels at Year 1, 2 and 3 • Evaluate anti-imlifidase IgG levels at year 1, 2 and 3 • Investigate the occurrence of AMR episodes after completed the feeder trial • Investigate the occurrence of other graft rejection episodes;Primary end point(s): The primary endpoint of this trial is the overall graft survival, evaluated at Year 3.;Timepoint(s) of evaluation of this end point: Year 3	—

Measure

Time frame

Main Objective: The primary objective of this trial is to evaluate kidney graft survival in subjects that have been treated with imlifidase or plasma exchange in association with AMR in trial 16-HMedIdeS-12 (referred to as the feeder trial).;Secondary Objective: • Evaluate overall graft survival at Year 1 and 2 • Evaluate patient survival at Year 3 • Evaluate kidney function at Year 1, 2 and 3 • Evaluate DSA levels at Year 1, 2 and 3 • Evaluate anti-imlifidase IgG levels at year 1, 2 and 3 • Investigate the occurrence of AMR episodes after completed the feeder trial • Investigate the occurrence of other graft rejection episodes;Primary end point(s): The primary endpoint of this trial is the overall graft survival, evaluated at Year 3.;Timepoint(s) of evaluation of this end point: Year 3

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Secondary

Measure	Time frame
Secondary end point(s): • Overall graft survival evaluated at Year 1 and 2 • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial;Timepoint(s) of evaluation of this end point: • Overall graft survival evaluated at screening, 1 and 2 Years • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial	—

Measure

Time frame

Secondary end point(s): • Overall graft survival evaluated at Year 1 and 2 • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial;Timepoint(s) of evaluation of this end point: • Overall graft survival evaluated at screening, 1 and 2 Years • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial

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Countries

Australia, Austria, France, Germany, Sweden, United States

Contacts

Public ContactClinical contact information

Hansa Biopharma

clinicalstudyinfo@hansabiopharma.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026