This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.
Reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. It has been reported that acteoside can reduce mesangium lesion of IgA nephrology-model ddy-mice, mainly by reducing the expressing of TGF-β1, reducing proliferation of mesangial cell and glomerular sclerosis. Research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. Thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy. We set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. After followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
Oral take and reh-acteoside (0.4g bid) for 8 weeks
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Remission of proteinuria (complete or partial)
Complete remission: UPCR (urinary protein creatinine ratio) \<300mg/g, plasma albumin in normal range, and stable serum creatinine level (fluctuation range \<15%); Partial remission: UPCR decreases more than 50% from baseline, plasma albumin \>30g/L, and stable serum creatinine level (fluctuation range \<15%).
Time frame: up to 8 weeks
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 8 weeks
Deacrase of hematuria
urine RBC decreases more than 50% from baseline
Time frame: up to 8 weeks
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