Trial · NCT03897205
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment | Start of treatment until 5 days following start of treatment | 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. |
| Secondary | Reduction in DSA Levels After Treatment | Screening until Day 180 | DSA levels were assessed at all visits throughout the study. The results are presented as reduction (%) from baseline. Clarification: The higher the reduction percentage the lower the remaining DSA level. Please observe that a negative reduction value represents an increase in DSA level from baseline. |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) Levels | Screening until Day 180 | eGFR as calculated from p-creatinine is a measure of kidney function. eGFR was assessed at all visits throughout the study. |
| Secondary | Urine Albumine/Creatinine Ratio | Pre-dose until Day 180 | The albumine/creatinine ratio in urine is a measure of kidney function. |
| Secondary | Number of Patients With Graft Loss Within 180 Days of Treatment | Screening until Day 180 | Information on patients who experienced graft loss was collected throughout the study. |
| Secondary | Number of Patients With Signs or no Signs of Transplant Glomerulopathy at Day 180 | Day 180 | Biopsies collected 180 days after treatment were analysed for signs of glomerulopathy. |
| Secondary | Number of Patients With Different Types of Kidney Histopathology Throughout the Trial | Screening, Day 29 and Day 180 | Kidney biopsies were assessed according to the Banff (2017) criteria at screening (baseline), Day 29, and Day 180. Abbreviations: AMR=Antibody mediated rejection, CMR=cell-mediated rejection |
| Secondary | Number of Patients With Resolved AMR as Assessed by Messenger Ribonucleic Acid (mRNA) Levels | Screening, Day 29, and Day 180 | Kidney biopsies were taken at screening, Day 29, and Day 180. Changes from baseline in mRNA levels were assessed as evidence of resolved AMR. |
| Secondary | Number of Administered Plasma Exchange (PE) and Immunoadsorption (IA) Sessions | Day 1 to Day 180 | Total number of administered PE and IA sessions to each treatment group are presented during the complete trial (Day 1 to Day 180) and for the time period: start of IVIg administration to Day 180. |
| Secondary | Total Serum Immunoglobulin G (IgG) Levels Until Administration of Intravenous Immunoglobulin (IVIg) | Pre-dose until Day 6 | Total serum IgG levels over time following treatment until administration of IVIg. Please observe, IVIg was initiated on Day 4 (before 96 h measurement) for the imlifidase group. |
| Secondary | Number of Patients With Intact IgG, Single-cleaved IgG (scIgG), F(ab')2 Fragments Following Treatment Until Administration of IVIg | Start of treatment (Day 1) up to administration of IVIg on Day 4 (imlifidase group) and until administration of IVIg within Day 15 (PE group) | Presence of IgG, scIgG, and F(ab')2 was analysed using sodium dodecyl-sulphate polyacrylamide gel electrophoresis (SDS-PAGE)/western blot. Of note, IVIg was administered on Day 4 (before 96 h measurement) to patients treated with imlifidase. Hence no analyses beyond this timepoint were performed for this group. |
| Secondary | DSA Functionality Determined by C1q Analysis Pre- and Post-treatment | Screening until Day 6 | An MFI value above 6000 is indicative of complement fixation. Analysis of DSA functionality assessed as mean MFI levels was done before and after treatment. |
| Secondary | Pharmacokinetic (PK) Profile of Imlifidase: Cmax | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | Cmax = Maximum observed plasma concentration of imlifidase following dosing |
| Secondary | PK Profile of Imlifidase: Tmax | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | Tmax = Time point for maximum observed plasma concentration of imlifidase following dosing |
| Secondary | PK Profile of Imlifidase: t1/2 | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | t1/2 = terminal half-life of imlifidase (refers to the time required for plasma concentration of a drug to decrease by 50%) Different mathematical models are available to describe how drugs are adsorbed, distributed, metabolised, and eliminated from the body. The time-concentration curve of imlifidase could be fitted to the so called 2-compartment model. This model divide the body into a central and an peripheral compartment. The central compartment consist of the plasma and tissues where the distribution is fast and the peripheral consists of tissues where the distribution of the drug is slower. As a result the elimination of imlifidase consists of an initial phase with a short half life (alpha-t1/2) and an elimination phase with a longer half-life (beta-t1/2). |
| Secondary | PK Profile of Imlifidase: AUC | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | Area under the imlifidase plasma concentration vs time curve (AUC) |
| Secondary | PK Profile of Imlifidase: CL | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | Clearance (CL) of imlifidase means the volume of blood cleared of imlifidase per unit of time. |
| Secondary | PK Profile of Imlifidase: Volume of Distribution (V) | Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15 | Vss = volume of distribution associated with steady state VZ = volume of distribution associated with the elimination phase |
| Secondary | Concentration of Anti-drug Antibodies (ADAs) | Screening until Day 180 | Samples were collected and analysed for presence of anti-imlifidase IgG throughout the study. Imlifidase is an IgG-degrading enzyme of Streptococcus pyogenes. Patients who have been exposed to Streptococcus prior to participating in this trial tested positive for ADA also before exposure to imlifidase. |
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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