Trial · NCT03157037
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Independent Renal Function at 6 Months | 6 months after dosing | Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis. |
| Secondary | Number of Patients With Independent Renal Function at 3 Months | 3 months after dosing | Number of patients without need for dialysis at 3 months. A patient with independent renal function is defined as a patient without need for dialysis. |
| Secondary | Renal Function at 3 and 6 Months | 3 and 6 months after imlifidase dosing | Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR was calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m\^2. Reduced kidney function is characterised by a decreased eGFR value. |
| Secondary | Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing | eGFR is a measure of kidney function. eGFR has been calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m\^2. Reduced kidney function is characterised by a decreased eGFR value. Number of patients per 4 different eGFR categories (0-15, 15-30, 30-60, ≥60 mL/min/1.73m\^2) are presented. A shift towards a higher category during the study indicates improved renal function over time. |
| 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 | Anti-GBM antibodies above a toxic level defined as \>20 U/mL. The level of anti-GBM antibodies was measured centrally using the Phadia ELiA(TM) anti-GBM kit. The enzyme-linked immunoassay (ELiA) is a fluorescence enzyme immunoassay. |
| Secondary | Number of Patients With Haematuria (Blood in Urine) | At 6 months after dosing | Haematuria was assessed using urine dipstick. The result was presented as: Negative/Trace/+1/+2/+3/+4. In the analysis results being +2 or above are considered as relevant. Haematuria was an inclusion criterion. All 15 patients had haematuria when included in the study. |
| Secondary | Change in Proteinuria During the Study | Pre-imlifidase, 3 and 6 months after imlifidase dosing | Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study . |
| Secondary | Number of PLEXs Needed Over Time | Pre-screening and up to Day 93 after imlifidase dosing | Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study. |
| Secondary | Pharmacokinetics of Imlifidase (Cmax) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Maximum observed plasma concentration of IdeS following dosing (Cmax) |
| Secondary | Pharmacokinetics of Imlifidase (AUC) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Area under the plasma concentration versus time curve (AUC) |
| Secondary | Pharmacokinetics of Imlifidase (t1/2) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Half-life during distribution phase (Alpha-t1/2) Half-life during elimination phase (Beta-t1/2) The results refers to harmonic mean. |
| Secondary | Pharmacokinetics of Imlifidase (CL) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Clearance (CL) is a measure of the ability of the body to clear imlifidase from plasma |
| Secondary | Pharmacokinetics of Imlifidase (Vz) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Vz = Volume of distribution during the elimination phase |
| Secondary | Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG) | Pre-dose up to 6 months after imlifidase administration | Imlifidase specifically cleaves all subclasses of human IgG rapidly and efficiently. The cleaving process involves two steps: (i) intact IgG to single cleaved IgG followed by (ii) single cleaved IgG to completely cleaved IgG (one F(ab')2- and one homodimeric Fc-fragment) The electroluminescence analysis method used measures the sum of intact and single cleaved IgG in serum. The efficacy of imlifidase is evaluated as remaining concentration of intact and single cleaved IgG in serum after treatment. |
| Secondary | Anti-imlifidase Antibodies (ADA) | Up to 6 months after dosing | Determination of anti-imlifidase antibody concentration |
| Secondary | Renal Histology | Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days) | Kidney biopsies were classified according to the histopathologic classification for antineutrophil cytoplasmic antibodies (ANCA)-associated glomerulonephritis developed by Berden et al. 2010. This classification has previously been applied in a study of 123 anti-GBM disease patients (von Daalen et al 2018). Histopathologic class: * Focal (≤50% normal glomeruli) * Crescentic (≥50% glomeruli with cellular crescents) * Mixed (\<50% normal, \<50%crescentic, \<50% globally sclerotic glomeruli) * Sclerotic (≥50% globally sclerotic glomeruli) In addition information on the histological activity and kidney outcome was provided. Focal class is associated with favourable kidney outcome, whereas sclerotic carries a poor outcome. Crescentic/mixed class could have an intermediate outcome between focal and sclerotic. Immunofluorescence performed at the local hospitals was also used to assess linear IgG deposits which is a hallmark of anti-GBM antibody disease. |
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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