E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute renal failure after heart surgery |
Akut njursvikt efter hjärtkirurgi
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E.1.1.1 | Medical condition in easily understood language |
Acute renal failure |
Akut njursvikt |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038447 |
E.1.2 | Term | Renal failure neonatal |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 |
To investigate the metabolism of hANP routinely given to newborn babies who develop acute renal failure associated with cardiac surgery. |
Att undersöka omsättningen i kroppen av läkemedlet hANP som rutinmässigt ges till nyfödda barn som utvecklar akut njursvikt i samband med hjärtkirurgi. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Ej tillämpligt |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children undergoing corrective heart surgery 2. Who develope acute renal failure 3. Will be treated with hANP 4. Age 1-12 months, 5. Dual-chamber physiology 6. Informed consent by parents/guardians |
1. Barn som genomgått korrigerande kirurgi för medfödda hjärtfel 2. Utvecklat akut njursvikt 3. Skall behandlas med hANP 4. Ålder 1-12 månader 5. Tvåkammarfysiologi 6. Signerat informerat samtycke från föräldrar/vårdnadshavare
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E.4 | Principal exclusion criteria |
Not applicable |
Ej tillämpligt |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Area under the curve (AUC), maximum concentration (Cmax), time to Cmax, clearance (CL), volume of distribution (Vd), half-life (t1 / 2) and mean residence time (MRT) and compartment modeling and physiological modeling. |
Area under curve (AUC), högsta koncentrationen (Cmax), tid till Cmax, clearance (CL), distributionsvolym (Vd), halveringstid (t1/2), mean residence time (MRT) samt compartment modeling och fysiologisk modeling. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T0 = Before starting treatment T1 = 1 hour after the start of treatment T2 = 2 hours after the start of treatment T4 = 4 hours after start T8 = 8 hours after start T16 = 16 hours after start T24 = 24 hours after start T32 = 32 hours after starting treatment T -1 = 1 hour before release T + 1 = 1 hour after release |
T0 = Innan behandlingsstart T1 = 1 timme efter behandlingsstart T2 = 2 timmar efter behandlingsstart T4 = 4 timmar efter behandlingsstart T8 = 8 timmar efter behandlingsstart T16 = 16 timmar efter behandlingsstart T24 = 24 timmar efter behandlingsstart T32 = 32 timmar efter behandlingsstart T -1 = 1 timme innan utsättning T +1 = 1 timme efter utsättning |
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E.5.2 | Secondary end point(s) |
Not applicable |
Ej tillämpligt |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Ej tillämpligt |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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.6.13.1 | Other scope of the trial description |
Denna explorativa pilotstudie syftar till att ge en orienterande bild av farmakologiska parametrar hos aktuell patientgrupp inför planering av framtida kliniska studier. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetics |
Orienterande farmakokinetik |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | 1 |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 of study is defined as the last blood sample, i.e. 1 hour after the ANP discontinuation |
Studien definieras som avslutad efter sista blodprovet dvs. 1 timme efter ANP-behandlingens utsättande |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 7 |