Status:
UNKNOWN
Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Proteinuria
Eligibility:
All Genders
19-70 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01512862
Start Date
January 1 2012
End Date
December 1 2013
Last Update
April 10 2012
Active Locations (3)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
2
Seoul National University Hospital
Seoul, South Korea, 110-744
3
SMG-SNU Boramae Medical Center
Seoul, South Korea, 156-707