Clinical trial NCT02160132: A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.
Official title: Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glomerulonephritis, IGA
Peripapillary Crescent
Necrosis
Steroid Nephropathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR\>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Mental aberrations
* Current or recent (within 30 days) exposure to any other investigational drugs.

Primary outcomes:
measure: Remission of proteinuria (complete or partial)
timeFrame: up to 6 months
Secondary outcomes:
measure: 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).
timeFrame: up to 6 months
measure: The longitudinal decline of kidney function(eGFR)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Department of Nephrology,Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Huizhou
country: China
facility: Department of Nephrology,Huizhou Municipal Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Department of Nephrology,1st Affiliated Hospital,Shenzhen University
state: Guangdong
city: Zhaoqing
country: China
facility: Department of Nephrology,1st People's Hospital of Zhaoqing
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Zongpei Jiang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.