E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
25-OH vitamin D deficiency and mineral - bone disorder in hemodialysis patients |
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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 | 10061292 |
E.1.2 | Term | Mineral metabolism disorder |
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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 assess the percentage of patients with appropriate control plasma levels of calcium, phosphorus, calcium x phosphorus product and intact parathormone following correction of the 25-OH vitamin D by oral administration of cholecalciferol (D-Cure ®). |
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E.2.2 | Secondary objectives of the trial |
• To assess the percentage of hemodialysed patients with 25-OH vitamin D deficiency (≤ 30 ng/mL) • To assess the effectiveness of weekly administration of 25.000 UI D-cure ® for 3 months to correct 25-OH vitamin D deficiency (> 30 ng/mL) • To evaluate the safety and tolerability of D-cure ® weekly dosing in the treatment of 25-OH vitamin D deficiency among dialysis patients • To explore associations between the 25-OH vitamin D levels and biological and clinical markers associated to mineral and bone disorder.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent • Age 18 years or older • End-stage renal disease on hemodialysis for at least 3 months (3 dialysis sessions or more per week) • Serum 25-OH vitamin D levels < 30 ng/mL
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E.4 | Principal exclusion criteria |
• Known hypersensibility to cholecalciferol or to any constituent of the study medication (D-cure ®) • Pregnancy or lactation period • Woman of childbearing potential without effective contraception • Cholecalciferol, calcitriol, paricalcitol or alfacalcidol dosage adjustment 1 month prior to enrolment • Serum corrected calcium level > 10.2 mg/dL • Participation in a clinical trial or receipt of investigational compound or treatment 3 months prior the enrolment • Parathyroidectomy • History of granulomatous disorder (sarcoidosis, tuberculosis) • History of malignancy with a life expectancy < 12 months
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of patients with K/DOQI recommended serum levels of calcium (8.5 - 9.5 mg/dL), phosphate (3.5 - 5.5 mg/dL), calcium x phosphate product (< 55 mg²/ dL²) and intact parathyroid hormone (150 - 300 pg/mL) after cholecalciferol (D - Cure ®) therapy for 25-OH vitamin D deficiency correction (≤ 30 ng / mL) |
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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 | Yes |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |