E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ischemia reperfusion injury in living donor kidney transplantation |
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E.1.1.1 | Medical condition in easily understood language |
Ischemia reperfusion injury in living donor kidney transplantation |
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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 improves renal function at 1 year by decreasing IRI short after transplantation.
Safety |
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E.2.2 | Secondary objectives of the trial |
To study whether exogenous alkaline phosphatase administered early in living donor kidney transplantation will:
(1) Improve eGFR at 3 months after transplantation
(2) Improved ‘rate of fall’ in creatinin at 72 hours after transplantation
(3) Dampen the release of pro-inflammatory cytokines (IL6, IL8, TNFα) in the first 24 hours
(4) Be associated with a decrease in the ‘urinary damage markers’ (retinol-binding protein, KIM1, NGAL). |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Microvasculature: mean perfuses vessel density (PVD) and the mean total vessel density (TVD) measured by video images of the sublingual microcirculation. |
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E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age >18
- Recipients of a living donor kidney
- First organ transplanation
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Second or subsequent organ transplantation
- Strict vegetarians or veganists. These individuals have higher potential risk to an allergic reaction to the infused bovine protein.
- History of allergy to bovine proteins
- Not standard immunosuppression at time of transplantation
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E.5 End points |
E.5.1 | Primary end point(s) |
Graft function at one year after kidney transplantation (iohexol clearance) |
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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) |
o eGFR and 24 hour urine creatinine clearance at 3 months
o Rate of fall in creatinin in the first 72 hours after transplantation
o Cytokine profiles in peripheral blood samples
o Urinary ‘kidney damage markers’: retinol binding protein; KIM1; NGAL
o Incidence of biopsy proven rejection
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |