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

September 5, 2016 updated by: Yonsei University
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang, Korea, Republic of, 41-0719
        • National Health Insurance Corporation Ilsan Hospital
      • Goyang, Korea, Republic of, 412-270
        • Kwandong University Myongji Hospital
      • Gunpo, Korea, Republic of, 435-040
        • Wongkwang University Sanbon Medical Center
      • Seongnam, Korea, Republic of, 435-040
        • CHA University Bundang Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha womans university medical center
      • Seoul, Korea, Republic of, 110-752
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: oral calcitriol
Calcio®
Drug: Calcitriol
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
NO_INTERVENTION: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
serum creatinine every 2month
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
check blood pressure at very first visit and every 2-month
changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
Time Frame: every 6month
urine marker check every 6month
every 6month
changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
Time Frame: every 6month
serum marker check every 6month
every 6month
changes in serum inflammatory markers (hsCRP, IL-6)
Time Frame: every 6month
serum marker check every 6month
every 6month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Tae-Hyun Yoo, MD, Ph.D, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IgA Nephropathy

Clinical Trials on Calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe