25-OH vitamin D deficiency and mineral - bone disorder in hemodialysis patients MedDRA version: 9.1 Level: LLT Classification code 10061292 Term: Mineral metabolism disorder
Conditions
Interventions
Trade Name: D Cure
Product Name: D-Cure
Pharmaceutical Form: Oral solution
INN or Proposed INN: cholecalciferol
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration num
Sponsors
Hôpital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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 ®).;Secondary Objective: • 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. ;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) | — |
Countries
Belgium
Outcome results
None listed