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

This study is currently recruiting participants.
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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ 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


Estimated Enrollment: 168
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral calcitriol
Calcio®
Drug: Calcitriol
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
No Intervention: placebo

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237028

Locations
Korea, Republic of
National Health Insurance Corporation Ilsan Hospital Recruiting
Goyang, Korea, Republic of, 41-0719
Contact: Tae-Ik Chang, MD    82-31-900-0246    tichang73@hanmail.net   
Kwandong University Myongji Hospital Recruiting
Goyang, Korea, Republic of, 412-270
Contact: Soo-Young Yoon, MD    82-31-810-5405    diva502@kd.ac.kr   
Contact: Sang-Cheol Lee, MD    82-31-810-5426    drjoy@kd.ac.kr   
Wongkwang University Sanbon Medical Center Recruiting
Gunpo, Korea, Republic of, 435-040
Contact: Hyun-Wook Kim, MD    82-31-390-2970    bluejayway@naver.com   
CHA University Bundang Medical Center Recruiting
Seongnam, Korea, Republic of, 435-040
Contact: Hyung-Jong Kim, MD    82-31-780-5895    khj04@cha.ac.kr   
Ewha Womans University Medical Center Recruiting
Seoul, Korea, Republic of, 158-710
Contact: Dong-Ryeol Ryu, MD    82-2-2650-2507    drryu@ewha.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-752
Contact: Dong-Ki Kim, MD    82-2-2072-2303    dkkim73@gmail.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Tae-Hyun Yoo, MD, Ph.D    82-2-2228-1989    yoosy0316@yuhs.ac   
Contact: Seung-Hyuk Han, MD, Ph.D    82-2-2228-1931    hansh@yuhs.ac   
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D         
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D Severance Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01237028     History of Changes
Other Study ID Numbers: 4-2010-0439
Study First Received: November 8, 2010
Last Updated: June 1, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014