E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibody-mediated rejection in kidney transplant patients |
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E.1.1.1 | Medical condition in easily understood language |
Rejection caused by antibodies in kidney transplant patients |
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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 |
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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). |
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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 |
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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 |
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E.4 | Principal exclusion criteria |
• Inability by the judgement of the investigator to participate in the trial for any other reason |
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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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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 |
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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 |
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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 |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 |
United States |
Austria |
France |
Germany |
Sweden |
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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
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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 |