E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyroidism (HPT) in subjects with CKD receiving hemodialysis |
Iperparatiroidismo Secondario (HPT) in soggetti con Insufficienza Renale Cronica (CKD) sottoposti a trattamento emodialitico. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 | 10038444 |
E.1.2 | Term | Renal failure chronic |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 |
To evaluate: Attenuation of the progression of coronary artery calcification (CAC) in hemodialysis subjects receiving a treatment regimen including cinacalcet and low dose of Vitamin D. |
Valutare: La riduzione della progressione di calcificazione delle arterie coronarie (CAC) in soggetti in emodialisi che ricevono un regime di trattamento che include cinacalcet e basse dosi di Vitamina D. |
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E.2.2 | Secondary objectives of the trial |
To evaluate: Attenuation of the progression of aortic calcification and aortic valve calcification. Proportion of subjects achieving > 15% progression of CAC. Absolute and percent changes in PTH, corrected calcium,phosphorus and Ca x P. Safety and tolerability of cinacalcet. |
valutare: La riduzione della progressione di calcificazione aortica. La riduzione della progressione di calcificazione delle valvole aortiche. Proporzione di soggetti ottenendo una progressione di CAC > 15% Modificazioni dei valori in assoluto ed in percentuale di PTH,calcio (Ca),fosforo (P) e prodotto calcio x fosforo (Ca x P) Sicurezza e tollerabilita' di cinacalcet |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults >= 18 years on hemodialysis for >= 6 months before study day 1 Intact PTH >300 pg/ml (bio-intact PTH > 160 pg/ml or 31.8 pmol/L) OR, intact PTH >= 150 pg/ml and <= 300 pg/ml (15.9-31.8 pmol/L); or biPTH 80-160 pg/ml (8.5-17.0 pmol/L) and subject is receiving active vitamin D therapy at time of PTH assessment, o and corrected serum Ca x P > 50 mg2/dl2 (3.9 mmoL2/L2) corrected serum calcium >= 8.4 mg/dl (2.1 mmol/L) Screening CAC score >= 30 |
Adulti >= 18 anni in emodialisi per >=6 mesi prima del giorno 1 di studio Valore di PTH intatto > 300 pg/mL ( 31.8 pmol/L); oppure bio-intatto PTH>160 pg/mL(17.0 pmol/L), Oppure iPHT >= 150 e <= 300 pg/ml (15.9-31.8 pmol/L),oppure bio-intatto PTH 80-160 pg/mL ( 8.5-17.0 pmol/L), e soggetti che hanno ricevuto terapia di vitamina D in forma attiva e corretti livelli sierici di Ca x P > 50 mg²/dl² (3.9 mmol ²/L² ) Corretti livelli di calcio siero >= 8.4 mg/dl (2.1 mmol 7L) Valore di CAC allo screening >= 30 |
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E.4 | Principal exclusion criteria |
Exclusion criteria: Current or previous use of bisphosphonates at any time Received non-calcium containing phosphate binders (sevelamer HCl, aluminum-containing phosphate binders, or lanthanum chloride) within 30 days prior to screening Received cinacalcet within 30 days prior to screening Started or required a change in HMG CoA reductase inhibitor dose (or other cholesterollowering medications) within 30 days before screening Active atrial fibrillation, history of coronary artery bypass grafting (CABG), history of coronary artery stents, aortic/cardiac valve replacement, aortic aneurysm |
Soggetti che hanno ricevuto chelanti del fosfato non contenenti calcio (sevelamer HCL, chelanti del fosfato contenenti alluminio oppure lantanio) entro 30 giorni prima dello screening. Soggetti che hanno ricevuto cinacalcet entro 30 giorni prima dello screening Precedente o attuale uso di biofosfonati Soggetti che hanno iniziato o richiesto un un cambio di dosaggio degli inbitori della HMG CoA reduttasi( oppure altri trattamenti ipocolesterolizzanti ) entro 30 giorni prima dello screening Fibrillazione atriale attiva, storia di bypass coronarico, storia di stent coronario, sostituzione della valvola aortica/cardiaca, aneurisma dell'aorta |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change from baseline in CAC score at week 52 |
Variazione percentuale dal basale del valore di CAC alla settimana 52 |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dosaggio flessibile di Vit. D attiva |
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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
| 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
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
| |
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 | 22 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 22 |
E.8.9.2 | In all countries concerned by the trial days | 0 |