E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ischemia reperfusion injury in kidneys transplanted from donors after cardiac death |
ischemie reperfusieschade in getransplanteerde nieren van overleden donoren na hartdood |
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E.1.1.1 | Medical condition in easily understood language |
hypoxic damage in transplanted kidneys from deceased donors |
nierschade door zuurstoftekort tijdens transplantatie nadat donor overleden is |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 study whether exogenous alkaline phosphatase can prevent ischemia reperfusion injury in deceased donor kidney transplantation and will thereby decrease the duration of delayed graft function. |
- Onderzoeken of exogene alkalische fosfatase ischemie-reperfusieschade bij niertransplantatie van overleden donoren kan voorkomen en daardoor de duur van vertraagde transplantaatfunctie |
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E.2.2 | Secondary objectives of the trial |
- Decrease mean duration of hospitalization after kidney transplantation - Decrease of incidence of persistent dialysis DGF (> 14 days) - Decrease incidence of DGF using functional and dialysis definition and a combination of the two - Decrease duration of DGF using functional and dialysis definition and a combination of the two - Improve fall of serum creatinine in the first week after transplantation - Improve kidney perfusion contrast renography at day 6 - Improve creatinine clearance at 3 months and 1 year after transplantation - Decrease proteinuria at 3 months and 1 year after transplantation - Improve estimated renal glomerular filtration rate (eGFR) 3mnth 1yr - Reduce primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months) - Reduce incidence of biopsy proven rejection within one year follow-up period - Improve all-cause mortality at day 28 and 90 and 1 year
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- Verlaging gemiddelde opnameduur na niertransplantatie - Afname incidentie van persisterende dialyse DGF (> 14 dagen) - Verlaag de incidentie van DGF met behulp van functionele en dialysedefinitie en een combinatie van beide - Verkort de duur van DGF met behulp van functionele en dialysedefinitie en een combinatie van beide - Verbetering van de daling van serumcreatinine in de eerste week na transplantatie - Verbeter nierperfusiecontrastrenografie op dag 6 - Verbetering van de creatinineklaring na 3 maanden en 1 jaar na transplantatie - Proteïnurie verminderen na 3 maanden en 1 jaar na transplantatie - Verbeterde geschatte renale glomerulaire filtratiesnelheid (eGFR) 3mnd 1yr - Vermindering van primaire non-functie (gedefinieerd als dialyse-afhankelijkheid of creatinineklaring <20 ml/min na 3 mnd) - Verminder de incidentie van door biopsie bewezen afstoting binnen een follow-upperiode van één jaar - Verbetering van de mortaliteit door alle oorzaken op dag 28 en 90 en 1 jaar |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age >18 - Recipients of a donor awaiting cardiac death on the intensive care (definition of a donor cardiac death type III according to the ‘Maastricht classification’) - Written informed consent
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- Leeftijd >18 - Ontvangers van een donor in afwachting van hartdood op de intensive care (definitie van een donor hartdood type III volgens de ‘Maastrichtclassificatie’) - Schriftelijke geïnformeerde toestemming |
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E.4 | Principal exclusion criteria |
- Strict vegetarians or vegans - History of allergy to bovine proteins
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- Strikte vegetariërs of veganisten - Geschiedenis van allergie voor rundereiwitten |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Difference between treatment and placebo group in duration of delayed graft failure (DGF). DGF is defined as need for dialysis, excluding short sessions for hyperkalemia. DGF is defined as need for dialysis, excluding single sessions for hyperkalemia. |
Onderzoeken of exogene alkalische fosfatase ischemie-reperfusieschade bij niertransplantatie van overleden donoren kan voorkomen en daardoor de duur van vertraagde transplantaatfunctie (fDGF) kan verkorten. DGF wordt gedefinieerd als behoefte aan dialyse, met uitzondering van enkele sessies voor hyperkaliëmie. |
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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) |
- Mean duration of hospitalization after kidney transplantation - Incidence of persistent dialysis DGF (> 14 days) - Incidence of DGF using functional and dialysis definition and a combination of the two - Duration of DGF using functional and dialysis definition and a combination of the two - Dall of serum creatinine in the first week after transplantation - Kidney perfusion contrast renography at day 6 - Creatinine clearance at 3 months and 1 year after transplantation - Proteinuria at 3 months and 1 year after transplantation - Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation - Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months) - Incidence of biopsy proven rejection within one year follow-up period - All-cause mortality at day 28 and 90 and 1 year
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- Gemiddelde opnameduur na niertransplantatie - Incidentie van persisterende dialyse DGF (> 14 dagen) - Incidentie van DGF met behulp van functionele en dialysedefinitie en een combinatie van beide - Duur van DGF met behulp van functionele en dialysedefinitie en een combinatie van beide - Dal van serumcreatinine in de eerste week na transplantatie - Nierperfusie contrast renografie op dag 6 - Creatinineklaring 3 maanden en 1 jaar na transplantatie - Proteïnurie 3 maanden en 1 jaar na transplantatie - Geschatte renale glomerulaire filtratiesnelheid (eGFR) berekend met MDRD en de CKD-epi-formule 3 maanden en 1 jaar na transplantatie - Primaire non-functie (gedefinieerd als dialyse-afhankelijkheid of creatinineklaring <20 ml/min na 3 maanden) - Incidentie van biopsie bewezen afstoting binnen een follow-up periode van één jaar - Sterfte door alle oorzaken op dag 28 en 90 en 1 jaar |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 days, 3 months, one year |
28 days, 3 months, one year |
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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 | 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 | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |