Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.

Overview

The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.

Full Title of Study: “Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Detailed Description

Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex(pGd-IgA1-IC)in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy

Interventions

  • Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
    • The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
  • Drug: Mycophenolate mofetil (MMF)
    • Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months

Arms, Groups and Cohorts

  • Experimental: TWH for the treatment of IgAN
    • Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
  • Active Comparator: MMF for IgAN
    • MMF for the treatment of IgAN for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients reaching remission
    • Time Frame: one year
    • (i) complete remission was defined as the absence of proteinuria (24-h urine protein < 0.4 g/24 h), serum albumin >35 g/L and Scr < 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of >50% of the baseline value with an Scr elevation of <15% of the baseline value; (iii) no response was defined as a 24-h urine protein >3.5 g/24h, or a decline < 50% of base- line value or increase and/or an Scr level >50% of the baseline value

Secondary Measures

  • Renal survival
    • Time Frame: one year
    • Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.

Participating in This Clinical Trial

Inclusion Criteria

  • urinary protein levels ≥1.0 g/24 h – estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine – 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl)) – peripheral blood white blood cell count ≥3000×109/L – no other cause for tubulointerstitial lesions – no history of immunomodulatory agent intake before renal biopsy – no systemic infection – age between 16 and 65 years Exclusion Criteria:

  • severe infections

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Youming Peng, Director of the Nephrology Institute – Second Xiangya Hospital of Central South University
  • Overall Official(s)
    • Shenghua Zhou, MD, Study Director, the second xiangya hospital of CSU
  • Overall Contact(s)
    • Youming Peng, M.D, 8615802604114

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