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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01237028

Collaborator

(none)

168

Enrollment

Locations

Arms

65.1

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Drug: Calcitriol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: oral calcitriol Calcio®	Drug: Calcitriol Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
No Intervention: placebo

Arm

Intervention/Treatment

Experimental: oral calcitriol

Calcio®

Drug: Calcitriol

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

No Intervention: placebo

Outcome Measures

Primary Outcome Measures

changes in proteinuria [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	National Health Insurance Corporation Ilsan Hospital	Goyang	Korea, Republic of	41-0719
2	Kwandong University Myongji Hospital	Goyang	Korea, Republic of	412-270
3	Wongkwang University Sanbon Medical Center	Gunpo	Korea, Republic of	435-040
4	CHA University Bundang Medical Center	Seongnam	Korea, Republic of	435-040
5	Seoul National University Hospital	Seoul	Korea, Republic of	110-752
6	Severance Hospital	Seoul	Korea, Republic of	120-752
7	Ewha Womans University Medical Center	Seoul	Korea, Republic of	158-710

Sponsors and Collaborators

Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01237028

Other Study ID Numbers:

4-2010-0439

First Posted:

Nov 9, 2010

Last Update Posted:

Sep 7, 2016

Last Verified:

Sep 1, 2016

Additional relevant MeSH terms:

Kidney Diseases

Glomerulonephritis, IGA

Calcitriol

Study Results

No Results Posted as of Sep 7, 2016