Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

Study Overview
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Brief Summary
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This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.

Detailed Description
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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.

Official Title
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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Conditions
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IGA Nephropathy

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Reh-acteoside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 14 70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0 3.5g/24h on two successive examinations. eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign). 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. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506). Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level. 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisolone<br>Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks | Drug: Prednisolone<br>* Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks<br>|
| Experimental: Reh-acteoside<br>Oral take reh-acteoside (0.4g bid) for 8 weeks | Drug: Reh-acteoside<br>* Oral take and reh-acteoside (0.4g bid) for 8 weeks<br>|
| Experimental: Reh-acteoside+Prednisolone<br>Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks | Drug: Prednisolone<br>* Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks<br>Drug: Reh-acteoside<br>* Oral take and reh-acteoside (0.4g bid) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%). | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 weeks | 
| Deacrase of hematuria | urine RBC decreases more than 50% from baseline | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IGA Nephropathy, proteinurien, Reh-acteoside, Prednisolone