E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibody-mediated rejection in kidney transplant patients |
|
E.1.1.1 | Medical condition in easily understood language |
Rejection caused by antibodies in kidney transplant patients |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023439 |
E.1.2 | Term | Kidney transplant rejection |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial is to evaluate kidney graft survival in subjects that have been treated with imlifidase or plasma exchange in association with AMR in trial 16-HMedIdeS-12 (referred to as the feeder trial). |
|
E.2.2 | Secondary objectives of the trial |
• Evaluate overall graft survival at Year 1 and 2 • Evaluate patient survival at Year 3 • Evaluate kidney function at Year 1, 2 and 3 • Evaluate DSA levels at Year 1, 2 and 3 • Evaluate anti-imlifidase IgG levels at year 1, 2 and 3 • Investigate the occurrence of AMR episodes after completed the feeder trial • Investigate the occurrence of other graft rejection episodes |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed Informed Consent obtained before any trial-related procedures • Willingness and ability to comply with the protocol • Previous treatment with imlifidase or plasma exchange in trial 16-HMedIdeS-12 |
|
E.4 | Principal exclusion criteria |
• Unsuitable to participate in the study for any reason, e.g., individuals who have been placed in an institution on the basis of an official or court order, or subjects who are dependent on the Sponsor, investigator or the study site, or any other reasons as judged by the investigator • Inability by the judgement of the investigator to participate in the trial for any other reason |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this trial is the overall graft survival, evaluated at Year 3. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Overall graft survival evaluated at Year 1 and 2 • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Overall graft survival evaluated at screening, 1 and 2 Years • Patient survival, evaluated at 3 years after start of treatment in feeder trial • Kidney function, as evaluated by eGFR, S/P-creatinine and albumin/creatinine ratio in urine at 1, 2, and 3 years after start of treatment in feeder trial • Proportions of subjects with presumed or biopsy proven AMR episodes within 3 years after start of treatment in feeder trial • Proportion of subjects with presumed or biopsy-proven rejection episodes, (other than AMR episodes) up to 3 years after start of treatment in feeder trial • DSA levels at 1, 2, and 3 years after start of treatment in feeder trial • Anti-imlifidase IgG at 1, 2, and 3 years after start of treatment in feeder trial |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
France |
Germany |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |