Trial · NCT03611621
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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, overall graft survival, was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored at the time of occurrence: withdrawal from the trial without graft loss, death not caused by graft loss, and end of trial without graft loss. | percentage | NUMBER |
| 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) | The overall patient survival was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored: withdrawal from the trial while alive, and end of trial while alive | percentage | NUMBER |
| 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) | Patients with a visit/assessment at year 5 | mL/min/1.73m2 | MEAN |
| 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) | Patients with a visit/assessment at year 5 | μmol/L | MEAN |
| 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) | Patients with a visit/assessment at year 5 | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Patients with a visit/assessment at year 5. Note: number of patients with suspected acute rejection episodes up until year 5. One (1) biopsy confirmed rejection episode (AMR) was reported for 1 patient approx. 9 months after transplantation. One (1) biopsy confirmed rejection episode reported in the current trial occurred in the feeder trial. Five (5) rejection episodes were not confirmed by biopsy. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Patients with a visit/assessment at year 5. Any medication (e.g. Intravenous immunoglobulin \[IVIg\]) given for graft rejection episodes | Participants | COUNT_OF_PARTICIPANTS |
| 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) | All patients with a comorbidity reported. Note: any single patient could have more than one comorbidity reported. | participants with comorbidity | NUMBER |
| 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 | Immunosuppressive medications were recorded for 30 of the 31 patients enrolled | participants | NUMBER |
| SECONDARY | Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | g/L | MEAN |
| 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) | All patients with a visit/assessment at year 5. Note: not all patients had an assessment reported at year 5. | percentage | MEAN |
| SECONDARY | Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes) | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | 10^9 thrombocytes/L | MEAN |
| SECONDARY | Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG) | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5. | g/L | MEAN |
| SECONDARY | Assessment of Donor Specific Antibodies (DSA) | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | Mean fluorescence intensity (MFI) | MEAN |
| SECONDARY | Assessment of the Presence of BK Virus | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | participants | NUMBER |
| SECONDARY | Assessment of the Immunogenicity of Imlifidase | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | mg/L | MEAN |
| 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) | All patients with a visit/assessment at year 5 | score on a scale | MEDIAN |
| 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) | All patients with a visit/assessment at year 5 | score on a scale | MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03611621/outcomes