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NCT03897205 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
A Phase 2 study, sponsored by Hansa Biopharma AB.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03897205: Completed Phase 2 study, sponsored by Hansa Biopharma AB.
NCT03897205 is a Phase 2 study that has completed, run by Hansa Biopharma AB. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03897205, a Phase 2 study, has completed, sponsored by Hansa Biopharma AB.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. The purpose was also to investigate and compare safety for these two treatments.
Primary Outcome
Maximum reduction (%) in the sum of DSA at any time point during the 5 days following the start of treatment. Only DSA with ≥1000 mean fluorescence intensity (MFI) at pre-treatment were included in the calculations. Clarification: The higher the maximum reduction percentage the lower the remaining DSA level.
Interventions
- DRUG Imlifidase
- OTHER Plasma Exchange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 2 |
What the finished NCT03897205 record still lists
NCT03897205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Imlifidase is the first listed.
NCT03897205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03897205 about?
NCT03897205 is a clinical study titled "An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients". The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidne...
What is the current status of trial NCT03897205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-04-30. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT03897205?
The interventions under investigation include: Imlifidase (DRUG), Plasma Exchange (OTHER).
Who is sponsoring clinical trial NCT03897205?
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 NCT03897205's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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