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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237028
• Other study ID #: 4-2010-0439
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: September 5, 2016
• Start date: March 2011
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kwandong University Myongji Hospital	Goyang
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Goyang
Korea, Republic of	Wongkwang University Sanbon Medical Center	Gunpo
Korea, Republic of	CHA University Bundang Medical Center	Seongnam
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	changes in serum creatinine	comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation	serum creatinine every 2month	No
Secondary	changes in systolic blood pressure and diastolic pressure	check systolic and diastolic blood pressure	check blood pressure at very first visit and every 2-month	No
Secondary	changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)	urine marker check every 6month	every 6month	No
Secondary	changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone	serum marker check every 6month	every 6month	No
Secondary	changes in serum inflammatory markers (hsCRP, IL-6)	serum marker check every 6month	every 6month	No