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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT01237028 |
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Date of registration:
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08/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
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Scientific title:
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Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01237028 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Tae-Hyun Yoo, MD, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Severance Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven Ig AN patients aged 20-70 years
- Patients with residual proteinuria > 500 mg/g creatinine despite renin-angiotensin
system blockade and adequate blood pressure control for more than 3 months
- Patients who give informed consent, and 4) estimated GFR >= 30 ml/min/1.73 m2.
Exclusion Criteria:
- patients < 20 years or > 70 years
- hypersensitivity to vitamin D analogs
- patients who need urgent dialysis
- hypercalcemia within 3 months (uncorrected serum calcium level > 10.2 mg/dL)
- clinical features of rapidly progressive glomerulonephritis
- life expectancy less than 24 months
- uncontrolled hypertension
- decompensated liver or lung disease
- symptomatic heart failure (NYHA class II-IV or LVEF < 40%)
- estimated GFR < 30 ml/min/1.73 m2.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Intervention(s)
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Drug: Calcitriol
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Primary Outcome(s)
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changes in proteinuria
[Time Frame: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month]
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Secondary Outcome(s)
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changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
[Time Frame: every 6month]
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changes in serum creatinine
[Time Frame: serum creatinine every 2month]
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changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
[Time Frame: every 6month]
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changes in systolic blood pressure and diastolic pressure
[Time Frame: check blood pressure at very first visit and every 2-month]
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changes in serum inflammatory markers (hsCRP, IL-6)
[Time Frame: every 6month]
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Secondary ID(s)
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4-2010-0439
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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