N/A
N=37
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Kidney Transplant Failure and Rejection
Bottom Line
View on ClinicalTrials.gov: NCT03611621 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. — 91 percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Imlifidase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hansa Biopharma AB
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. |
91 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. |
92 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). |
50.74 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). |
141.3 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). |
14; 13; 3 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. |
23; 7 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. |
2 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. |
9; 3; 3; 4; 4; 2 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. |
29; 1; 30; 30 | — |
| SECONDARY Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) |
121.5 | — |
| SECONDARY Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes) |
0.4; 1.3; 20.3; 9.9; 56.7 | — |
| SECONDARY Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes) |
225 | — |
| SECONDARY Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG) |
10.04 | — |
| SECONDARY Assessment of Donor Specific Antibodies (DSA) |
803 | — |
| SECONDARY Assessment of the Presence of BK Virus |
0; 28 | — |
| SECONDARY Assessment of the Immunogenicity of Imlifidase |
26.70 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L). |
80.00; 0.86; 1.00; 0.79 | — |
| SECONDARY Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF). |
79.4; 89.0; 76.0; 86.9; 86.0; 74.0 | — |
Summary
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected.
This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent obtained before any study-related procedures
- Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06
Exclusion Criteria
- Individuals deemed unable to comply with the protocol
- Inability by the judgment of the investigator to participate in the study for other reasons
Data sourced from ClinicalTrials.gov (NCT03611621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.