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

Purpose

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

Condition	Intervention
IgA Nephropathy	Drug: Calcitriol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D

Drug Information available for: Calcitriol

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

changes in proteinuria [ Time Frame: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month ] [ Designated as safety issue: No ]
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein

Secondary Outcome Measures:

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

Estimated Enrollment:	168
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237028

Locations

Korea, Republic of
National Health Insurance Corporation Ilsan Hospital	Recruiting
Goyang, Korea, Republic of, 41-0719
Contact: Tae-Ik Chang, MD 82-31-900-0246 tichang73@hanmail.net
Kwandong University Myongji Hospital	Recruiting
Goyang, Korea, Republic of, 412-270
Contact: Soo-Young Yoon, MD 82-31-810-5405 diva502@kd.ac.kr
Contact: Sang-Cheol Lee, MD 82-31-810-5426 drjoy@kd.ac.kr
Wongkwang University Sanbon Medical Center	Recruiting
Gunpo, Korea, Republic of, 435-040
Contact: Hyun-Wook Kim, MD 82-31-390-2970 bluejayway@naver.com
CHA University Bundang Medical Center	Recruiting
Seongnam, Korea, Republic of, 435-040
Contact: Hyung-Jong Kim, MD 82-31-780-5895 khj04@cha.ac.kr
Ewha Womans University Medical Center	Recruiting
Seoul, Korea, Republic of, 158-710
Contact: Dong-Ryeol Ryu, MD 82-2-2650-2507 drryu@ewha.ac.kr
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-752
Contact: Dong-Ki Kim, MD 82-2-2072-2303 dkkim73@gmail.com
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Tae-Hyun Yoo, MD, Ph.D 82-2-2228-1989 yoosy0316@yuhs.ac
Contact: Seung-Hyuk Han, MD, Ph.D 82-2-2228-1931 hansh@yuhs.ac
Principal Investigator: Tae-Hyun Yoo, MD, Ph.D

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator:

Tae-Hyun Yoo, MD, Ph.D

Severance Hospital

More Information

No publications provided

Responsible Party:	Tae-Hyun Yoo / Assistant Professor, Severance Hospital, Depatment of Internal Medicine
ClinicalTrials.gov Identifier:	NCT01237028 History of Changes
Other Study ID Numbers:	4-2010-0439
Study First Received:	November 8, 2010
Last Updated:	April 18, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Calcitriol
Vitamins
Micronutrients

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013