A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation

NCT05049850 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-HMedIdeS-16
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether imlifidase in combination with bortezomib, belatacept, rituximab and IVIg can suppress donor specific antibodies (DSA) and the occurrence of antibody-mediated rejection (AMR) in highly sensitized patients with chronic kidney disease with a positive crossmatch towards their living donor during a period of 3 months from transplantation.

Conditions

Kidney Transplantation in Highly Sensitized Patients

Keywords

Highly sensitized; Kidney transplantation; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With DSA Rebound

  The recurrence of DSA may cause AMR and increased risk of graft loss. Due to the early termination of the trial the primary endpoint was assessed as the incidence of DSA rebound of either immunodominant or total DSA to a mean fluorescence intensity (MFI) level that was ≥50% of the pre-imlifidase value up to 3 months after transplantation (trial day 91).

  Up to 3 months after transplantation

Secondary Outcomes (20)

• Proportion of Patients With Kidney Biopsy Proven AMR

  Up to 6 months after transplantation

• Proportion of Patient With DSA Rebound

  Up to 6 months after transplantation

• Proportion of Patients With Negative FCXM

  Up to 24 hours after imlifidase treatment

• Levels of DSA

  Within 4 hours before imlifidase until Day 181

• Levels of Complement Binding (C1q) DSA

  Within 4 hours before imlifidase until Day 181

Study Arms (1)

Imlifidase

EXPERIMENTAL

Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)

Drug: Imlifidase

Interventions

Imlifidase DRUG

Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly specific for IgG.

Also known as: IdeS, HMED-IdeS

Imlifidase

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent obtained before any trial-related procedures
• Male or female age 18 to 70 years at the time of screening
• Highly sensitized patients registered on the UNOS waiting list for kidney transplantation, with either of the following:
• cPRA ≥ 99.9%
• cPRA ≥ 98% and have been in kidney paired donation or kidney paired exchange programs for at least 1 year
• A positive crossmatch towards a living donor
• Willingness and ability to comply with the protocol

You may not qualify if:

• Previous treatment with imlifidase
• Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment
• Breast-feeding or pregnancy
• Women of child-bearing potential not willing or able to practice FDA-approved forms of contraception. Two medically acceptable methods of highly effective contraception must be used for the duration of the study (e.g. oral, transdermal, intravaginal, injectable or implantable contraceptive; intrauterine device; intrauterine hormone-releasing system; vasectomized partner; bilateral tubal occlusion; or double-barrier method). For a woman to be considered postmenopausal this ascertainment must be made according to medical records and clinical history and may be aided by measurement of elevated postmenopausal serum gonadotropin levels (FSH).
• ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
• Positive serology for HIV
• Clinical signs of HBV, HCV, CMV, or EBV infection
• EBV seronegative or with unknown EBV serostatus
• Positive SARS-CoV-2 tests at any time point from screening to transplantation
• Active tuberculosis
• Ongoing serious infections as judged by the investigator
• Severe other conditions requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease
• A history of a proven hypercoagulable condition
• Present, or history of, thrombotic thrombocytopenic purpura (TTP) or known familial history of TTP
• Intake of investigational drugs (other than imlifidase) within 5 half-lives

Sponsors & Collaborators

• Hansa Biopharma AB: lead

Study Sites (1)

NYU Langone Health Transplant Institute

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Mac-1-like protein, Streptococcus

Results Point of Contact

• Title: Study Director
• Organization: Hansa Biopharma AB

clinicalstudyinfo@hansabiopharma.com

+46 46 16 56 70

Study Officials

• Clinical Operations

  Hansa Biopharma AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: December 16, 2022
• Primary Completion: February 5, 2024
• Study Completion: May 8, 2024
• Last Updated: October 21, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)