Trial · NCT03611621
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | 5 years after first dose of imlifidase (in the feeder study) | The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | 5 years after first dose of imlifidase (in the feeder study) | Overall patient survival defined as time from transplantation to death for any cause |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by analysis of plasma (P)-creatinine |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by proteinuria by dipstick analysis |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018). The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR): * a biopsy was taken at the time of the graft rejection episode * histological evidence of an AMR was reported in the pathology report * presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications). |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study) | Recording of comorbidities up until year 5 after treatment with imlifidase |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5 | Recording of concomitant immunosuppressive medication |
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | 5 years after first dose of imlifidase (in the feeder study) | Blood samples were analyzed for hemoglobulin (Hb) |
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes) | 5 years after first dose of imlifidase (in the feeder study) | Differential analysis of leucocytes was done in blood samples |
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes) | 5 years after first dose of imlifidase (in the feeder study) | Blood samples were analyzed for thrombocytes |
| Secondary | Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG) | 5 years after first dose of imlifidase (in the feeder study) | Blood samples were analyzed for total IgG levels. |
| Secondary | Assessment of Donor Specific Antibodies (DSA) | 5 years after first dose of imlifidase (in the feeder study) | DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis |
| Secondary | Assessment of the Presence of BK Virus | 5 years after first dose of imlifidase (in the feeder study) | Blood samples were analyzed for antibodies towards BK virus |
| Secondary | Assessment of the Immunogenicity of Imlifidase | 5 years after first dose of imlifidase (in the feeder study) | Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L). | 5 years after first dose of imlifidase (in the feeder study) | Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L) EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA \[-0.109 - 1.000\], France \[-0.530 - 1.000\], Denmark \[-0.624 - 1.000\], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden. The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF). | 5 years after first dose of imlifidase (in the feeder study) | Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF) Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life. |
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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