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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: November 8, 2010
Last updated: September 5, 2016
Last verified: September 2016
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.

Condition Intervention
IgA Nephropathy
Drug: Calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 168
Study Start Date: March 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral calcitriol
Drug: Calcitriol
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
No Intervention: placebo


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01237028

Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Goyang, Korea, Republic of, 41-0719
Kwandong University Myongji Hospital
Goyang, Korea, Republic of, 412-270
Wongkwang University Sanbon Medical Center
Gunpo, Korea, Republic of, 435-040
CHA University Bundang Medical Center
Seongnam, Korea, Republic of, 435-040
Seoul National University Hospital
Seoul, Korea, Republic of, 110-752
Severance Hospital
Seoul, Korea, Republic of, 120-752
Ewha Womans University Medical Center
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Yonsei University
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D Severance Hospital
  More Information

Responsible Party: Yonsei University Identifier: NCT01237028     History of Changes
Other Study ID Numbers: 4-2010-0439
Study First Received: November 8, 2010
Last Updated: September 5, 2016

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 25, 2017