E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
LES TRANSPLANTES RENAUX AVEC HYPERPARATHYROIDIE PERSISTANTE |
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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 | 10020705 |
E.1.2 | Term | Hyperparathyroidism |
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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 |
Efficacité du cinacalcet sur les paramètres du métabolisme osseux chez les transplantés rénaux avec une hyperparathyroïdie persistante à 12 mois : Ostéodensitométrie |
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E.2.2 | Secondary objectives of the trial |
Effet sur la fonction rénale, les différents paramètres du métabolisme phosphocalcique et tolérance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- PTH 1-84 > 70 pg/ml (selon K/DOQI : pour clairance supérieure à 30ml/min) - calcémie plasmatique totale corrigée ≥ 2,6 mmol/L (à 2 reprises, pour des normes = 2.2 – 2.6 mmol/l) – l’intervalle de temps maximum durant lequel ces deux calcémies doivent être retrouvées est de 3 mois. - Age ≥ 18 ans - Clairance de la créatinine ≥ 30 ml/min/1,73m² (selon la formule MDRD) et protéinurie < 1,5 g/24h - Délai après transplantation ≥12 mois - Immunosuppression stable - Consentement éclairé signé |
|
E.4 | Principal exclusion criteria |
- Grossesse ou allaitement - Insuffisance hépatocellulaire modérée à sévère (score de Child-Pugh) - Traitement par : thiazidiques, kétoconazole, itraconazole, télithromycine, voriconazole, ritonavir, rifampicine, fluvoxamine, ciprofloxacine, flécaïnide, propafénone, métoprolol, désipramine et antidépresseurs tricycliques, nortriptyline, clomipramine et IRSð dans les 3 semaines ou actuel - Hypersensibilité au cinacalcet ou à un de ses excipients - Rejet d’allogreffe |
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E.5 End points |
E.5.1 | Primary end point(s) |
- DMO (M0 – M6 - M12) en mg/cm² - PAO et CTX (M0 – M6 – M12) |
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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 | No |
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 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |