A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.
NCT ID: NCT02160132
Last Updated: 2015-03-03
Study Results
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Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A 1-2-3Group
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Methylprednisolone(intravenously in the 1st-2nd-3rd month )
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
B 1-3-5Group
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Methylprednisolone(intravenously in the 1st-3rd-5th month)
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Interventions
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Methylprednisolone(intravenously in the 1st-2nd-3rd month )
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Methylprednisolone(intravenously in the 1st-3rd-5th month)
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Eligibility Criteria
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Inclusion Criteria
* Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.
* Average urinary protein excretion of 0.5\~3.5g/24h on two successive examinations.
* eGFR ≥ 50 ml/min/1.73 m2
* Willingness to sign an informed consent.
Exclusion Criteria
* Rapidly progressive nephritic syndrome (crescent formation≥50%).
* Acute renal failure, including rapidly progressive IgAN.
* Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
* Date of renal biopsy exceeds more than 30 days.
* Cirrhosis, chronic active liver disease.
* History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
* Any Active systemic infection or history of serious infection within one month.
* Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
* Active tuberculosis
* Malignant hypertension that is difficult to be controlled by oral drugs.
* Known allergy, contraindication or intolerance to the steroids.
* Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
* Malignant tumors
* Excessive drinking or drug abuse
* Mental aberrations
* Current or recent (within 30 days) exposure to any other investigational drugs.
14 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
The Sixth Affiliated Hospital of Sun Yat-Sen University
Principal Investigators
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Zongpei Jiang, M.D. & Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, China
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, China
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, China
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liang M, Xiong L, Li A, Zhou J, Huang Y, Huang M, Zhang X, Shi H, Su N, Wei Y, Jiang Z. The effectiveness and safety of corticosteroid therapy for IgA nephropathy with crescents: a prospective, randomized, controlled study. BMC Nephrol. 2022 Jan 21;23(1):40. doi: 10.1186/s12882-022-02661-6.
Other Identifiers
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Usix-IgAN-001
Identifier Type: -
Identifier Source: org_study_id
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