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Completed

NCT Number: NCT01237028

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwandong University Myongji Hospital, Goyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcitriol

Drug

Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)

    Time frame: every 6month

    urine marker check every 6month

  4. changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone

    Time frame: every 6month

    serum marker check every 6month

  5. changes in serum inflammatory markers (hsCRP, IL-6)

    Time frame: every 6month

    serum marker check every 6month

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2010
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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