Trial · NCT03157037
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Independent Renal Function at 6 Months | 6 months after dosing | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Independent Renal Function at 3 Months | 3 months after dosing | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Function at 3 and 6 Months | 3 and 6 months after imlifidase dosing | Only patients who were alive and dialysis independent at respective analysis time (3 and 6 months) were included in this analysis because assessment of eGFR is not considered meaningful for patients in dialysis. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing | Only patients who were alive and dialysis independent at each specific analysis time are included in this analysis because eGFR is not applicable for patients in dialysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits | Predose up to 6 months after dosing | Number of study visits with a toxic level are presented instead of number of patient days with an anti-GBM level \>20 U/mL as was the original plan. | participants | NUMBER |
| SECONDARY | Number of Patients With Haematuria (Blood in Urine) | At 6 months after dosing | Data was missing for 5 of the 15 patients at 6 months. | Patients with haematuria (+2 or above) | NUMBER |
| SECONDARY | Change in Proteinuria During the Study | Pre-imlifidase, 3 and 6 months after imlifidase dosing | Some patients had missing data at some visits | g/mol | MEAN |
| SECONDARY | Number of PLEXs Needed Over Time | Pre-screening and up to Day 93 after imlifidase dosing | Number of PLEX performed | NUMBER | |
| SECONDARY | Pharmacokinetics of Imlifidase (Cmax) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | µg/mL | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetics of Imlifidase (AUC) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | h*µg/mL | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetics of Imlifidase (t1/2) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | h | MEAN | |
| SECONDARY | Pharmacokinetics of Imlifidase (CL) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | mL/h/kg | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetics of Imlifidase (Vz) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | L/kg | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG) | Pre-dose up to 6 months after imlifidase administration | Some patients had missing data at some timepoints | mg/mL | MEAN |
| SECONDARY | Anti-imlifidase Antibodies (ADA) | Up to 6 months after dosing | Some missing data at Day 50, Day 93 and Day 180 | mg/L | MEAN |
| SECONDARY | Renal Histology | Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days) | During the study, 14 kidney biopsies were taken from 10 of the 15 included patients. 10 biopsies were taken before administration of imlifidase and 4 after administration of imlifidase. | Biopsies | NUMBER |
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
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GET https://conductscience.org/api/trials/v1/NCT03157037/outcomes