Chronic renal failure, stage 3-4 MedDRA version: 14.0 Level: PT Classification code 10038444 Term: Renal failure chronic System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Detremin 20,000 I.U./ml oral drops, solution
Product Name: Vitamin D3 Forte Renapharma
Product Code: Vitamin D3 Forte Renapharma
Pharmaceutical Form: Oral drops, solution
Pharmaceutical fo
Sponsors
Renapharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females aged 18-85 • A calculated GFR of 59 to 15 mL/min/1.73 m2 body surface according to the Modification of Diet in Renal Disease (MDRD) formula • Intact PTH above 6.8 pmol/L (70 pg/mL) • Calcidiol levels below 75 nmol/L (30 ng/mL) • Have signed informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Assumed need for dialysis or renal transplantation within six months • Ionized calcium above 1.30 mmol/L • Ongoing acute infectious or inflammatory disease. Ongoing chronic inflammatory disease other than chronic glomerulonephritis or systemic diseases with renal involvement • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. • Kidney transplant, known granulomatous disease, malabsorption, primary hyperparathyroidism, malignancy or other disease with effect on mineral metabolism • Ongoing treatment with parakalcitol, calcimimetics or a daily intake of pharmaceutical preparations containing >400 IE of vitamin D. • Planned vacation trip, during the study period, to a sunny country outside Sweden • Contraindication for Vitamin D3 Forte Renapharma®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether there is a difference in the mean change from baseline of the blood levels of parathyroid hormone (PTH) between patients receiving cholecalciferol compared with patients receiving cholecalciferol placebo after 12 weeks’ treatment. ;Secondary Objective: The following secondary variable will be assessed after 6 weeks: • Mean change in blood levels of PTH. Further, the following secondary variables will be assessed after 6 and 12 weeks: • To Investigate whether there is a difference between the two treatment groups with respect to change in PTH levels after 6 weeks, and to investigate individual changes. Further to investigate differences between the two treatment in the change from baseline in musculoskeletal function and fatigue. ;Primary end point(s): Mean change from baseline in the levels of PTH after 12 weeks’ treatment ;Timepoint(s) of evaluation of this end point: After 12 weeks´ of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables: Mean change from baseline after 6 to 12 weeks in the levels of grip strength, fatigue questionnaire, fatigue on visual analogue scale. Exploratory analyses: calcidiol and calcitriol levels, biointact (1-84) PTH, FGF23, ionized calcium, phosphate (Pi), GFR estimated from cystatin C levels, and renal fractional excretion (FE) of Ca and Pi. ;Timepoint(s) of evaluation of this end point: After 6 and 12 weeks respectively | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
Monitour AB
Outcome results
None listed