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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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.
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGDepartment of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGDepartment of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Remission of proteinuria (complete or partial)
Time frame: up to 6 months
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).
Time frame: up to 6 months
The longitudinal decline of kidney function(eGFR)
Time frame: up to 6 months
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Guangzhou, Guangdong, China
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
RECRUITINGDepartment of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, China
RECRUITINGDepartment of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China
RECRUITING