Trial · NCT05049850
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | Kidney Function Assessed by Estimated Glomerular Filtration Rate (eGFR) | Up to 6 months after transplantation | Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR will be calculated as described by the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterized by a decreased eGFR value. |
| Secondary | Kidney Function Assessed by Protein/Creatinine Ratio in Urine | Up to 6 months after transplantation | The protein/creatinine ratio in urine is a measure of kidney function. Will be measured unless patients are anuric. |
| Secondary | Imlifidase Pharmacokinetics (AUC) | Within 4 hours before imlifidase dose until Day 15 | AUC = Area under the imlifidase plasma concentration versus time curve |
| Secondary | Imlifidase Pharmacokinetics (Cmax) | Within 4 hours before imlifidase dose until Day 15 | Cmax = Maximum observed plasma concentration of imlifidase following dosing |
| Secondary | Imlifidase Pharmacokinetics (Tmax) | Within 4 hours before imlifidase dose until Day 15 | tmax = Time point for maximum observed plasma concentration of imlifidase following dosing |
| Secondary | Imlifidase Pharmacokinetics (t1/2) | Within 4 hours before imlifidase dose until Day 15 | t1/2 = Terminal half-life of imlifidase, the time taken for concentration of imlifidase to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma. t1/2 alpha = alpha phase (distribution/elimination) half-life, an initial phase of rapid decrease in plasma concentration. t1/2 beta = beta phase (elimination) half-life, a phase of gradual decrease in plasma concentration after the alpha phase. |
| Secondary | Imlifidase Pharmacokinetics (CL) | Within 4 hours before imlifidase dose until Day 15 | CL = Clearance of imlifidase |
| Secondary | Imlifidase Pharmacokinetics (Vz) | Within 4 hours before imlifidase dose until Day 15 | Vz = Apparent volume of distribution during terminal phase |
| Secondary | Pharmacodynamics | Within 4 hours before imlifidase dose until Day 10 | Concentration of IgG in patient serum will be measured. Scoring of IgG fragments will be done. |
| Secondary | Anti-drug Antibodies (ADA) Levels | Up to 6 months after imlifidase | Immunogenicity towards imlifidase will be assessed by the measurement of ADA levels in patient serum using a customized ImmunoCAP analysis. |
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.
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