Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01673204
Eligibility Criteria:
Inclusion Criteria:
* patients age 19-80 years
* Clinically proven diabetic nephropathy
* MDRD eGFR \>= 30mL/min/1.73m2
* Patients with residual urine protein/creatinine ratio \>= 200mg/g
* Adequate blood pressure control as treated systolic blood pressure \<=140 or diastolic \<=90 mmHg with RAS inhibitor for more than 3months
* Serum intact PTH \<500 mg/dL
* Serum calcium \<10.2 mg/dL
* Patients who have not been treated vitamin D within the 3months prior to signing the informed consent form
Exclusion Criteria:
* Patients age \<19 years or \> 80years
* Patients with rapidly progressive glomerulonephritis
* Patients requiring renal replacement therapy immediately
* Hypercalcemia(Uncorrected serum calcium level \>10.2 mg/dL) within recent 3month
* Malignant hypertension
* Heart failure (New York Heart Association functional class II to IV or LVEF \<40%)
* Severe chronic obstructive lung disease
* Decompensated liver disease (ALT \>3X upper normal limit)
* Known allergy or hypersensitivity to vitamin D
* Current treatment with steroids and/or immunosuppressive agents
* Active primary malignancy requiring treatment or survival limits less than 2years
* History of noncompliance to medical regimen
* Inability to give an informed consent or to cooperate with researchers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT01673204
Study Brief:
Protocol Section:
NCT01673204