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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01237028
First received: November 8, 2010
Last updated: June 1, 2013
Last verified: June 2013

November 8, 2010
June 1, 2013
December 2010
December 2013   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    urine marker check every 6month
  • changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone [ Time Frame: every 6month ] [ Designated as safety issue: No ]
    serum marker check every 6month
  • changes in serum inflammatory markers (hsCRP, IL-6) [ Time Frame: every 6month ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.
 
Recruiting
168
December 2013
December 2013   (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.
Both
20 Years to 70 Years
No
Korea, Republic of
 
NCT01237028
4-2010-0439
No
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D Severance Hospital
Yonsei University
June 2013

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