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Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237028
First Posted: November 9, 2010
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
November 8, 2010
November 9, 2010
September 7, 2016
March 2011
August 2016   (Final data collection date for primary outcome measure)
changes in proteinuria [ Time Frame: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month ]
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein
Not Provided
Complete list of historical versions of study NCT01237028 on ClinicalTrials.gov Archive Site
  • changes in serum creatinine [ Time Frame: serum creatinine every 2month ]
    comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation
  • changes in systolic blood pressure and diastolic pressure [ Time Frame: check blood pressure at very first visit and every 2-month ]
    check systolic and diastolic blood pressure
  • changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha) [ Time Frame: every 6month ]
    urine marker check every 6month
  • changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone [ Time Frame: every 6month ]
    serum marker check every 6month
  • changes in serum inflammatory markers (hsCRP, IL-6) [ Time Frame: every 6month ]
    serum marker check every 6month
Not Provided
Not Provided
Not Provided
 
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
IgA Nephropathy
Drug: Calcitriol
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
  • Experimental: oral calcitriol
    Calcio®
    Intervention: Drug: Calcitriol
  • No Intervention: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
August 2016
August 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01237028
4-2010-0439
No
Not Provided
Not Provided
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D Severance Hospital
Yonsei University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP