NCT01237028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

5.4 years

First QC Date

November 8, 2010

Last Update Submit

September 5, 2016

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • changes in proteinuria

    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 Outcomes (5)

  • changes in serum creatinine

    serum creatinine every 2month

  • changes in systolic blood pressure and diastolic 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)

    every 6month

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

    every 6month

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

    every 6month

Study Arms (2)

oral calcitriol

EXPERIMENTAL

Calcio®

Drug: Calcitriol

placebo

NO INTERVENTION

Interventions

CalcitriolDRUG

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

oral calcitriol

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

National Health Insurance Corporation Ilsan Hospital

Goyang, 41-0719, South Korea

Location

Kwandong University Myongji Hospital

Goyang, 412-270, South Korea

Location

Wongkwang University Sanbon Medical Center

Gunpo, 435-040, South Korea

Location

CHA University Bundang Medical Center

Seongnam, 435-040, South Korea

Location

Seoul National University Hospital

Seoul, 110-752, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Ewha Womans University Medical Center

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Tae-Hyun Yoo, MD, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

March 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

KR(7)