E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050432 |
E.1.2 | Term | Prophylaxis against heart transplant rejection |
E.1.2 | System Organ Class | 100000004865 |
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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 major aim of this extension study is to evaluate the long-term (i.e. 10 - 12 years) effect of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE main study (Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41).
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E.2.2 | Secondary objectives of the trial |
Quality of life will be examined using three validated questionnaires, i.e. the SF-36, EQ 5D, and the BDI form. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who 1)participated in the SCHEDULE 12-month main study, and who 2) are coming for a regular annual clinic visit 10 to 12 years after randomization in the main study 3) are willing to provide a separate signed patient informed consent for this follow-up study |
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E.4 | Principal exclusion criteria |
Patients with a cardiac retransplant since the original SCHEDULE study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the estimated glomerular filtration rate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
10-12 years after randomisation in the SCHEDULE trial |
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E.5.2 | Secondary end point(s) |
• Degree of of CAV evaluated by coronary angiography • Myocardial structure and function by echocardiography assessment • Exercise capacity evaluated by Cardiopulmonary Exercise Testing • Quality of life by SF-36 (Minnesota Living with Heart Failure Questionnaire), Euro Quality of Life 5D (EQ 5D), and Beck Depression Inventory (BDI) form • Number of adverse events (AEs)/serious adverse events (SAEs) • Presence of donor specific antibodies (DSA)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
10-12 years after randomisation in the SCHEDULE 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 | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |