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Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
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.
Age
14 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 1, 2014
Primary Completion Date
December 1, 2016
Completion Date
December 1, 2016
Last Updated
March 3, 2015
180
ESTIMATED participants
Methylprednisolone(intravenously in the 1st-2nd-3rd month )
DRUG
Methylprednisolone(intravenously in the 1st-3rd-5th month)
DRUG
Lead Sponsor
Sun Yat-sen University
NCT06565910
NCT07297836
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