Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
ENROLLING_BY_INVITATIONSeoul National University Hospital
Seoul, South Korea
RECRUITINGSMG-SNU Boramae Medical Center
Seoul, South Korea
ENROLLING_BY_INVITATIONChanges in proteinuria
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
Time frame: 6, 12 months after administration
Changes in renal function
Comparison of in serum creatinine level from baseline
Time frame: 3, 6, 9 and 12 months
Changes in urinary renal damage markers
Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline
Time frame: 6, 12 months
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