E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
kidney disease after pulmonary transplant |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038474 |
E.1.2 | Term | Renal insufficiency |
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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 obtain a significative reduction of slope of curve after one year of treatment |
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E.2.2 | Secondary objectives of the trial |
to evaluate graft immunological and infective complications |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
eta' > 18 anni Maschi o femmine seguiti in follow-up presso il nostro centro in regime ambulatoriale, trapianto, di polmone singolo o doppio o cuore polmone, da almeno 6 mesi alla data di inclusione nello studio, valori di creatinina persistentemente (per la durata del periodo di screening) >/= a 1.50 mg/dl, quadro istologico di nefrotossicita' cronica da ciclosporina
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E.4 | Principal exclusion criteria |
Saranno esclusi pazienti con, ad esame istologico, presenza di nefropatia primitiva o secondaria (ad es. nefrite interstiziale, glomerulosclerosi diabetica, glomerulosclerosi ipertensiva con ialinosi arteriolare intimale), riscontro di proteinuria significativa > di 0.6 gr/24 ore, riceventi di trapianto renale, riceventi di trapianto polmonare (polmone singolo o doppio, o cuore polmone) da meno di 6 mesi all’atto del reclutamento, portatori nel post-trapianto di una patologia neoplastica sia cutanea che viscerale o ematologica, con significativo grado di compromissione tossica midollare (>/= a 2: secondo i criteri del NCI corrispondenti ad una conta nel sangue periferico di neutrofili </= 1500/mcl e/o di piastrine </= 75.000 /mcl), con evidenza di infezione o colonizzazione cronica delle vie aeree o dei seni paranasali da parte di batteri multireristenti o funghi, con infezione cronica da Virus epatite B o C, con persistente incremento di EBVDNA-emia > 5000 gEq/100.000 cellule mononucleate controllate a tempo -3 e 0, con un declino funzionale del graft tale da configurare una diagnosi di rigetto cronico (sindrome da bronchiolite obliterante) di grado >2 (sulla base delle recenti linee guida ISHLT), con stenosi significative a livello delle anastomosi bronchiali complicate da evidenza di cronica colonizzazione batterica o fungina, gia' inclusi in altri protocolli di trattamento sperimentali, con nota ipersensibilita' o che abbiano presentato reazioni avverse con tacrolimus o everolimus.
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E.5 End points |
E.5.1 | Primary end point(s) |
significative reduction of slope of curve after one year of treatment. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |