Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

Seoul National University

Status and phase

Unknown

Phase 4

Conditions

Proteinuria

Treatments

Drug: Placebo

Drug: Calcitriol

Study type

Interventional

Funder types

Other

Identifiers

NCT01512862

SNUH-CCTO

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Nondiabetic kidney disease patients aged 19-70 years
MDRD GFR ≥ 30 mL/min/1.73m2
Patients with residual urine protein/creatinine ratio > 200 mg/g
Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
Normotensive patients untreated with RAS inhibitors
Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form

Exclusion criteria

Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
Patients with rapidly progressive glomerulonephritis
Patients requiring renal replacement therapy immediately
Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
Malignant hypertension
Heart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)
Severe chronic obstructive lung disease
Decompensated liver disease
Known allergy or hypersensitivity to vitamin D
Current treatment with steroids and/or immunosuppressive agents
No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
History of noncompliance to medical regimen
Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)