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Sections: Correlations,
Clinical Trials, and HPO
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Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active or chronic active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments. 20 patients will be treated with imlifidase and 10 with PE.
Description: Maximum reduction (%) in the sum of DSAs at any time point during the 5 days following the start of treatment. Only DSAs with a pre-dose MFI ≥1000 will be included in the calculations
Measure: Maximum reduction in mean DSA level at any time point during the 5 days following the start of treatment Time: Start of treatment until 5 days following start of treatmentDescription: DSA levels will be assessed at all visits throughout the study.
Measure: DSA levels up to 180 days after treatment Time: Screening until Day 180Description: HLA-antibodies levels will be assessed at all visits throughout the study.
Measure: HLA-antibodies levels up to 180 days after treatment Time: Screening until Day 180Description: P-creatinine is a measure of kidney function. P-creatinine will be assessed at all visits throughout the study.
Measure: P-creatinine levels up to 180 days after treatment Time: Screening until Day 180Description: eGFR as calculated from p-creatinine is a measure of kidney function. eGFR will be assessed at all visits throughout the study.
Measure: eGFR levels up to 180 days after treatment Time: Screening until Day 180Description: The albumine/creatinine ratio in urine is a measure of kidney function. Urine sampling for analysis of albumine and creatinine will be done at all visits throughout the study.
Measure: Albumin/creatinine ratio in urine up to 180 days after treatment Time: Screening until 180 days after treatmentDescription: Information on graft loss will be collected throughout the study and proportion of subjects with graft loss will be reported.
Measure: Proportion of subjects with graft loss within 180 days of treatment Time: Screening until Day 180Description: The biopsy collected 180 days after treatment will be analysed for signs of glomerulopathy and proportion of subjects with signs of transplant glomerulopathy will be reported
Measure: Proportion of subjects with signs of transplant glomerulopathy 180 days after treatment Time: Day 180Description: Kidney biopsies will be assessed according to the Banff (2017) criteria pre-dose (screening) and at day 29 and 180.
Measure: Change from baseline in histopathology at day 29 and day 180 after treatment Time: Screening, 29 days and 180 days after treatmentDescription: Kidney biopsies will be taken at screening, day 29 and 180 and assessed for mRNA levels. Changes from baseline will be presented. If kidney biopsy is performed before screening, mRNA levels will be evaluated on day 29 and day 180 (no baseline will be available).
Measure: Change from baseline in mRNA levels in kidney biopsies at day 29 and day 180 after treatment Time: Screening, Day 29 and Day 180Description: Type, frequency and intensity of treatment emergent adverse events (TEAEs) and post-treatment AEs. An AE is regarded as a TEAE if occurring up to Day 29 after start of treatment.
Measure: Safety as evaluated by AEs Time: Start of treatment until Day 180Description: The number of PE sessions given throughout the study will be recorded in the CRF
Measure: Number of sessions with PE Time: Start of treatment until Day 180Description: Reduction of total serum IgG is defined as YES if the subject's minimum IgG value at any timepoint following the start of treatment and prior administration of IVIg is less than 5% of the baseline level. Proportion of subjects with a reduction of total serum IgG until administration of IVIg will be reported.
Measure: Proportion of subjects with reduction of total serum IgG following treatment until administration of IVIg Time: Start of treatment (Day 1) up to administration of IVIg on Day 4Description: Intact IgG is analysed using SDS-PAGE/western blot. The endpoint is met if no detectable intact IgG is found at any time point following treatment until administration of IVIg.
Measure: Proportion of subjects with no intact IgG following treatment until administration of IVIg. Time: Start of treatment (Day 1) up to administration of IVIg on Day 4Description: Analysis of DSA functionality assessed as mean MFI levels will be done at all visits throughout the study.
Measure: DSA functionality determined by C1q or C3d analysis pre- and post-treatment Time: Screening until Day 180Description: Cmax = Maximum observed plasma concentration of imlifidase following dosing
Measure: PK profile of imlifidase: Cmax Time: Start of treatment until Day 15Description: Tmax = Time point for maximum observed plasma concentration of imlifidase following dosing
Measure: PK profile of imlifidase: Tmax Time: Start of treatment until Day 15Description: t1/2 = terminal half-life of imlifidase
Measure: PK profile of imlifidase: t1/2 Time: Start of treatment until Day 15Description: AUC = Area under the imlifidase plasma concentration vs time curve
Measure: PK profile of imlifidase: AUC Time: Start of treatment until Day 15Description: CL = Clearance of imlifidase
Measure: PK profile of imlifidase: CL Time: Start of treatment until Day 15Description: V = Volume of distribution
Measure: PK profile of imlifidase: V Time: Start of treatment until Day 15Description: Samples will be collected and analysed for presence anti-imlifidase IgE and anti-imlifidase IgG throughout the study.
Measure: Proportion of patients with anti-drug antibodies (ADAs) Time: Screening until Day 180Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports