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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcitriol
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Health Insurance Corporation Ilsan Hospital
  • Kwandong University Myongji Hospital
  • Wongkwang University Sanbon Medical Center
  • CHA University Bundang Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • Ewha Womans University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oral calcitriol

placebo

Arm Description

Calcio®

Outcomes

Primary Outcome Measures

changes in proteinuria
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein

Secondary Outcome Measures

changes in serum creatinine
comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation
changes in systolic blood pressure and diastolic pressure
check systolic and diastolic blood pressure
changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
urine marker check every 6month
changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
serum marker check every 6month
changes in serum inflammatory markers (hsCRP, IL-6)
serum marker check every 6month

Full Information

First Posted
November 8, 2010
Last Updated
September 5, 2016
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01237028
Brief Title
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
Official Title
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral calcitriol
Arm Type
Experimental
Arm Description
Calcio®
Arm Title
placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Description
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
Primary Outcome Measure Information:
Title
changes in proteinuria
Description
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein
Time Frame
random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month
Secondary Outcome Measure Information:
Title
changes in serum creatinine
Description
comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation
Time Frame
serum creatinine every 2month
Title
changes in systolic blood pressure and diastolic pressure
Description
check systolic and diastolic blood pressure
Time Frame
check blood pressure at very first visit and every 2-month
Title
changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
Description
urine marker check every 6month
Time Frame
every 6month
Title
changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
Description
serum marker check every 6month
Time Frame
every 6month
Title
changes in serum inflammatory markers (hsCRP, IL-6)
Description
serum marker check every 6month
Time Frame
every 6month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Hyun Yoo, MD, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Goyang
ZIP/Postal Code
41-0719
Country
Korea, Republic of
Facility Name
Kwandong University Myongji Hospital
City
Goyang
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
Wongkwang University Sanbon Medical Center
City
Gunpo
ZIP/Postal Code
435-040
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center
City
Seongnam
ZIP/Postal Code
435-040
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-752
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Ewha Womans University Medical Center
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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