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

NCT04711850 | Terminated Results FDA Drug

• 2 other identifiers: 20-HMedIdes-182020-004777-49
• Study Type: observational
• Target: 18
• Locations: 3 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Graft Survival at Year 3

  Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Data table show number of patients with a functioning graft at Year 3.

  3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)

Secondary Outcomes (9)

• Overall Graft Survival at Year 2

  2 years after start of AMR treatment in feeder study (16-HMedIdeS-12)

• Overall Graft Survival at Year 1

  1 year after start of AMR treatment in feeder study (16-HMedIdeS-12)

• Patient Survival at Year 3

  3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)

• Kidney Function as Evaluated by eGFR

  1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)

• Kidney Function as Evaluated by S/P-creatinine

  1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)

Study Arms (2)

Imlifidase treatment in feeder Study 16-HMedIdeS-12

No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.

Drug: Imlifidase

Plasma exchange (PE) treatment in feeder Study 16-HMedIdeS-12

No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.

Interventions

Imlifidase DRUG

Immunoglobulin G degrading enzyme of Streptococcus pyogenes

Also known as: IdeS, HMED-IdeS

Imlifidase treatment in feeder Study 16-HMedIdeS-12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been treated with imlifidase or plasma exchange in the feeder study 16-HMedIdeS-12 may be included.

You may qualify if:

• 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 the trial 16-HMedIdeS-12
• Note: The primary objective of this trial is overall graft survival after treatment with imlifidase or plasma exchange. Therefore, subjects can also be included even if the subject did not fully complete the feeder trial follow up but was dosed with imlifidase or plasma exchange in the trial 16-HMedIdeS-12.

You may not qualify if:

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

Sponsors & Collaborators

• Hansa Biopharma AB: lead

Study Sites (7)

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW

Vienna, 1090, Austria

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

Grenoble, 38043, France

Location

Hôpital Saint-Louis. Service de Néphrologie et Transplantation

Paris, 75475, France

Location

Hôpital Necker - Service de Néphrologie - Transplantation

Paris, 75742, France

Location

Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care

Berlin, 13353, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Related Publications (1)

• Halleck F, Bohmig GA, Couzi L, Rostaing L, Einecke G, Lefaucheur C, Legendre C, Montgomery R, Hughes P, Chandraker A, Wyburn K, Halloran P, Maldonado AQ, Sjoholm K, Runstrom A, Lefevre P, Tollemar J, Jordan S. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection. Clin Transplant. 2024 Jul;38(7):e15383. doi: 10.1111/ctr.15383.

  PMID: 39023092 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected for DSA and ADA may be stored for a maximum of 5 years after completion of the trial. A full chain of custody is maintained for all samples throughout their life cycle.

MeSH Terms

Interventions

Mac-1-like protein, Streptococcus

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Vice President Research and Development
• Organization: Hansa Biopharma AB

info@hansabiopharma.com

+4646165670

Study Officials

• Clinical Operations

  Hansa Biopharma AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 20, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: May 28, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (4); DE (2)