A 12-week clinical double-blind, randomised study of vitamin D versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).
- Conditions
- Chronic renal failure, stage 3-4MedDRA version: 14.0Level: PTClassification code 10038444Term: Renal failure chronicSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2011-002586-38-SE
- Lead Sponsor
- Renapharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
•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
•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®
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>•Mean change in blood levels of PTH. <br>Further, the following secondary variables will be assessed after 6 and 12 weeks: <br>•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. <br>;Primary end point(s): Mean change from baseline in the levels of PTH after 12 weeks’ treatment<br>;Timepoint(s) of evaluation of this end point: After 12 weeks´ of treatment
- Secondary Outcome Measures
Name Time Method 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