Trial · NCT05049850
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
NCT05049850, Phase 2, Terminated, Hansa Biopharma AB; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation. Trials, record NCT05049850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05049850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
- NCT number
- NCT05049850
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Hansa Biopharma AB
- Conditions
- Kidney Transplantation in Highly Sensitized Patients
- Interventions
- Imlifidase
- First posted
- 2021-09-20
- Last updated
- 2025-10-21
- Results first posted
- 2025-03-17
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With DSA Rebound | Up to 3 months after transplantation | 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). |
| Secondary | Proportion of Patients With Kidney Biopsy Proven AMR | Up to 6 months after transplantation | The standardized international Banff classification 2019 for assessment of renal allograft biopsies will be used to assess AMRs reported from the study based on for cause and protocol biopsies. |
| Secondary | Proportion of Patient With DSA Rebound | Up to 6 months after transplantation | See description to primary outcome measure |
| Secondary | Proportion of Patients With Negative FCXM | Up to 24 hours after imlifidase treatment | Imlifidase is highly efficacious in converting a positive crossmatch to a negative |
| Secondary | Levels of DSA | Within 4 hours before imlifidase until Day 181 | Analysis of DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' DSAs. |
| Secondary | Levels of Complement Binding (C1q) DSA | Within 4 hours before imlifidase until Day 181 | Analysis of C1q DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' C1q DSAs. |
| Secondary | Number of Participants With Graft Survival | 6 months after transplantation | Graft survival will be summarized by end of trial. |
| Secondary | Patients Survival | 6 months after transplantation | Patient survival will be summarized by end of trial. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 6 months after transplantation | Safety is assessed as type, frequency and intensity of adverse events (AEs)/serious adverse events (SAEs) including clinically relevant changes in clinical laboratory tests, vital signs and ECG) |
| Secondary | Kidney Function Assessed by Creatinine | Up to 6 months after transplantation | P-creatinine is a measure of kidney function. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With DSA Rebound | Up to 3 months after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients With Kidney Biopsy Proven AMR | Up to 6 months after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patient With DSA Rebound | Up to 6 months after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients With Negative FCXM | Up to 24 hours after imlifidase treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Levels of DSA | Within 4 hours before imlifidase until Day 181 | Only 2 of 3 patients had data for DSA collected at the Day 181 timepoint, for patient 2 data from an unscheduled visit at day 139 is presented. | MFI | NUMBER |
| SECONDARY | Levels of Complement Binding (C1q) DSA | Within 4 hours before imlifidase until Day 181 | Samples for assessment of DSA, including Cq1 DSA, were collected. However, the central laboratory assigned to Cq1 DSA analyzes was never activated due to the premature trial termination, hence analysis of Cq1 DSA was not performed. | ||
| SECONDARY | Number of Participants With Graft Survival | 6 months after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients Survival | 6 months after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 6 months after transplantation | Results for adverse events is presented in the section Reported Adverse Events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Kidney Function Assessed by Creatinine | Up to 6 months after transplantation | μmol/L | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With DSA Rebound | Imlifidase | 0 | Participants | ||
| Proportion of Patients With Kidney Biopsy Proven AMR | Imlifidase | 1 | Participants | ||
| Proportion of Patient With DSA Rebound | Imlifidase | 0 | Participants | ||
| Proportion of Patients With Negative FCXM | Imlifidase | 3 | Participants | ||
| Levels of DSA | Imlifidase | Patient 1, pre-dose | 22311 | MFI | |
| Levels of DSA | Imlifidase | Patient 1, Day 181 | 8619 | MFI | |
| Levels of DSA | Imlifidase | Patient 2, pre-dose | 8526 | MFI | |
| Levels of DSA | Imlifidase | Patient 2, Day 139 | 2172 | MFI | |
| Levels of DSA | Imlifidase | Patient 3, pre-dose | 9994 | MFI | |
| Levels of DSA | Imlifidase | Patient 3, Day 181 | 149 | MFI |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imlifidase | 3 | |
| Overall Study | COMPLETED | Imlifidase | 3 | |
| Overall Study | NOT COMPLETED | Imlifidase | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Imlifidase | 2 | 3 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imlifidase | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Imlifidase | 1 | 3 | 1 |
| other | Haemorrhoids | Gastrointestinal disorders | Imlifidase | 1 | 3 | 1 |
| other | Small intestinal obstruction | Gastrointestinal disorders | Imlifidase | 1 | 3 | 1 |
| other | Abdominal infection | Infections and infestations | Imlifidase | 1 | 3 | 1 |
| other | Delayed graft function | Injury, poisoning and procedural complications | Imlifidase | 1 | 3 | 1 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Imlifidase | 1 | 3 | 1 |
| other | Alanine aminotransferase increased | Investigations | Imlifidase | 2 | 3 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Imlifidase | 2 | 3 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imlifidase | 0 | 3 |
| Total, other adverse events | Imlifidase | 3 | 3 |
| Total, serious adverse events | Imlifidase | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05049850
GET https://conductscience.org/api/trials/v1/NCT05049850/registered?page=2