E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of the rejection in adult patients receiving a de-novo renal transplant in combination with Neoral and corticosteroids |
Prevenzione del rigetto in pazienti adulti con trapianto di rene de-novo, in associazione a Neoral e corticosteroidi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023439 |
E.1.2 | Term | Kidney transplant rejection |
E.1.2 | System Organ Class | 10021428 - Immune system 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 |
Primary objective: To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months. |
Dimostrare che almeno uno dei regimi terapeutici con RAD001 non e` inferiore al regime terapeutico con Myfortic per l'endpoint primario composito di efficacia (rigetto acuto confermato da biopsia, perdita del trapianto, decesso o perdita al follow-up) a 12 mesi. |
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E.2.2 | Secondary objectives of the trial |
Main secondary objectives Efficacy: To compare the incidence of graft loss, death or loss to follow up (composite) between Certican and Myfortic treatment arms at 12 months post-transplantation. Safety: To compare renal function (calculated GFR using the MDRD formula (Coresh et. al. 2003) between Certican treatment arms and the Myfortic treatment arm at 12 months post-transplantation. Population: The study population will consist of a representative group of male and female transplant recipients 18-70 years of age undergoing primary renal transplantation. Eight hundred and twenty-five patients are planned to be enrolled. |
Confrontare l'incidenza complessiva di perdita del trapianto,decesso o perdita al follow-up nei due gruppi con RAD001 rispetto al Myfortic a 12 mesi.Dimostrare che la funzionalita` renale nei gruppi in trattamento con RAD001 a 12 mesi dal trapianto e` simile a quella del gruppo Myfortic.La funzionalita` renale sara` misurata con la velocita` di filtrazione glomerulare calcolata con la formula MDRD. |
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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 |
PHARMACOGENETIC: Vers: Date: Title: Objectives:
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FARMACOGENETICA: Vers: Data: Titolo: Obiettivi:
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E.3 | Principal inclusion criteria |
Inclusion criteria Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating Recipients of primary cadaveric, living unrelated or non HLA identical living related donor Patients who have given written informed consent to participate in the study |
Criteri di inclusione: Pazienti di entrambi i sessi, di eta` compresa tra 18 e 70 anni che saranno sottoposti a trapianto di rene da donatore cadavere oppure donatore vivente non apparentato o non HLA-identico. Consenso informato scritto. L'organo trapiantato deve essere funzionante (produzione di urine e diminuzione dei valori di creatininemia entro 24 ore dal trapianto) al momento della randomizzazione. Le donne in eta` fertile non devono essere in gravidanza o allattamento. Per gravidanza si intende il periodo che va dal momento del concepimento al termine della gestazione; tale condizione deve essere confermata da un test hCG positivo (> 5 mIU/ml). |
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E.4 | Principal exclusion criteria |
Exclusion criteria Cold ischemia time >40 hours, non-heartbeating donor , donor age >65 Patients with platelet count <100,000/mm at the evaluation before randomization. Patients with an absolute neutrophil count of < 1,500/mm³ at baseline before surgery or white blood cell count of < 4,500/mm³ Patients who are recipients of multiple solid organ transplants, or who previously received an organ transplant Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable Patients who have an abnormal liver profile such as ALT, AST, Alk Phos or total bilirubin >3 times the ULN Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole, cisapride or lovastatin Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin |
Criteri di esclusione principali: Tempo di ischemia fredda >40 ore. Soggetti riceventi un organo proveniente da un donatore a cuore non battente. Eta` del donatore superiore a 65 anni. Conta piastrinica <100.000/mm3 al momento della randomizzazione. Conta assoluta dei neutrofili <1.500/mm3 o conta leucocitaria <4.500/mm3 al basale (pre-tx). Trapianto multiorgano, o precedente trapianto di altro organo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary objective: To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months. |
Dimostrare che almeno uno dei regimi terapeutici con RAD001 non e` inferiore al regime terapeutico con Myfortic per l'endpoint primario composito di efficacia (rigetto acuto confermato da biopsia, perdita del trapianto, decesso o perdita al follow-up) a 12 mesi. |
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 41 |
E.8.9.1 | In the Member State concerned days | 0 |