Trial · NCT05049850
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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 | |
| SECONDARY | Kidney Function Assessed by Estimated Glomerular Filtration Rate (eGFR) | Up to 6 months after transplantation | mL/min/1.73m2 | MEDIAN | |
| SECONDARY | Kidney Function Assessed by Protein/Creatinine Ratio in Urine | Up to 6 months after transplantation | Only 2 of the 3 patients had data collected at the Day 181 timepoint. | mg/g | MEDIAN |
| SECONDARY | Imlifidase Pharmacokinetics (AUC) | Within 4 hours before imlifidase dose until Day 15 | h×μg/mL | MEDIAN | |
| SECONDARY | Imlifidase Pharmacokinetics (Cmax) | Within 4 hours before imlifidase dose until Day 15 | μg/mL | MEDIAN | |
| SECONDARY | Imlifidase Pharmacokinetics (Tmax) | Within 4 hours before imlifidase dose until Day 15 | h | MEDIAN | |
| SECONDARY | Imlifidase Pharmacokinetics (t1/2) | Within 4 hours before imlifidase dose until Day 15 | h | MEDIAN | |
| SECONDARY | Imlifidase Pharmacokinetics (CL) | Within 4 hours before imlifidase dose until Day 15 | mL/h/kg | MEDIAN | |
| SECONDARY | Imlifidase Pharmacokinetics (Vz) | Within 4 hours before imlifidase dose until Day 15 | L/kg | MEDIAN | |
| SECONDARY | Pharmacodynamics | Within 4 hours before imlifidase dose until Day 10 | g/L | MEDIAN | |
| SECONDARY | Anti-drug Antibodies (ADA) Levels | Up to 6 months after imlifidase | mg/L | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05049850/outcomes