A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
1 other identifier
interventional
180
1 country
6
Brief Summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 3, 2015
March 1, 2015
2.5 years
June 3, 2014
March 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Remission of proteinuria (complete or partial)
up to 6 months
Secondary Outcomes (2)
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).
up to 6 months
The longitudinal decline of kidney function(eGFR)
up to 6 months
Study Arms (2)
A 1-2-3Group
EXPERIMENTALMethylprednisolone 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
ACTIVE COMPARATORMethylprednisolone 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
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 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
You may qualify if:
- Age 14\~65 years, regardless of gender
- 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.
You may not qualify if:
- Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, 518000, China
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, 526020, China
Related Publications (1)
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.
PMID: 35062886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zongpei Jiang, M.D. & Ph.D.
The Sixth Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Sixth Affiliated Hospital of Sun Yat-Sen University
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 10, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 3, 2015
Record last verified: 2015-03