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NCT05049850 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
A Phase 2 study, sponsored by Hansa Biopharma AB.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT05049850: Clinical Trial Phase 2 study, sponsored by Hansa Biopharma AB.
NCT05049850 is a Phase 2 study that was terminated before completion, run by Hansa Biopharma AB. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05049850, a Phase 2 study, was terminated before completion, sponsored by Hansa Biopharma AB.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Imlifidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 2 |
Why NCT05049850 stopped before completion
NCT05049850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Imlifidase is the first listed.
NCT05049850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05049850 about?
NCT05049850 is a clinical study titled "A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation". 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 cros...
What is the current status of trial NCT05049850?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-12-16. Estimated completion is 2024-05-08.
What interventions are being tested in trial NCT05049850?
The interventions under investigation include: Imlifidase (DRUG).
Who is sponsoring clinical trial NCT05049850?
This trial is sponsored by Hansa Biopharma AB, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05049850's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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