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

Overview

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

Full Title of Study: “Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Detailed Description

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.

Interventions

  • Drug: Prednisolone
    • Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
  • Drug: Reh-acteoside
    • Oral take and reh-acteoside (0.4g bid) for 8 weeks

Arms, Groups and Cohorts

  • Active Comparator: Prednisolone
    • Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
  • Experimental: Reh-acteoside
    • Oral take reh-acteoside (0.4g bid) for 8 weeks
  • Experimental: Reh-acteoside+Prednisolone
    • Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Remission of proteinuria (complete or partial)
    • Time Frame: up to 8 weeks
    • 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%).

Secondary Measures

  • Deterioration of renal function
    • Time Frame: up to 8 weeks
    • 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
  • Deacrase of hematuria
    • Time Frame: up to 8 weeks
    • urine RBC decreases more than 50% from baseline

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanhong Deng, The Sixth Affiliated Hospital of Sun Yat-Sen University – Sun Yat-sen University
  • Overall Official(s)
    • Zongpei Jiang, M.D. & Ph.D., Principal Investigator, The Sixth Affiliated Hospital,Sun Yat-Sen University
  • Overall Contact(s)
    • Zongpei Jiang, M.D. & Ph.D., 8620-38379727, jx.home@medmail.com.cn

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