E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute kidney injury which is associated with on-pump cardiac surgery |
|
E.1.1.1 | Medical condition in easily understood language |
Acute kidney injury which is associated with on-pump cardiac surgery |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
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 |
To demonstrate the safety of intravenous hemin in patients with high risk of acute kidney injury after on-pump cardiac surgery |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficiency of preoperative administration of hemin to reduce the incidence of postoperative acute kidney injury in the context of cardiac surgery. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults, capable of giving consent personally ; elective on-pump cardiac surgery (ie. valvular surgery and/or CABG) ; high risk of postoperative acute kidney injury as defined by a renal STS score > 5.2% and/or basal estimated glomerular filtration rate < 55 ml/min/1.73m2 as defined by CKD-EPI equation. |
|
E.4 | Principal exclusion criteria |
Minor of age, pregnancy, CHILD C cirrhosis, infectious endocarditis, emergent cardiac surgery, preoperative end-stage renal disease, preoperative use of renal replacement therapy, transplanted organs, active neoplasia, allergy to one components of hemin |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety study: incidence of hemin-related side effects (superficial thrombophlebitis at the site of injection, headache), incidence of other complications |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 24h after cardiac surgery until day 7 ; at the time of discharge. |
|
E.5.2 | Secondary end point(s) |
(1) Modulation of the severity and/or reduction of the incidence of postoperative acute kidney injury as defined by 2012 KDIGO criteria. (2) quantification of heme oxygenate induction at 24h |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 24h after cardiac surgery until day 7 ; at the time of discharge. |
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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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | No |
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
|
The end will be at the end of the recruitment. An interim analysis will be done after 50% of patients per group. Following the results, an interruption of the study will be discussed with the local ethical committee. |
|
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 |