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

Second Xiangya Hospital of Central South University300 enrolled

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

IgA Nephropathy

Interventions

Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)DRUG

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.

Mycophenolate mofetil (MMF)DRUG

Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The second Xiangya Hospital of CSU

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

Number of patients reaching remission

(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

Time frame: one year

Secondary Outcomes

Renal survival

Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.

Time frame: one year

Central Contacts

Youming Peng, M.D

CONTACT

8615802604114

Data from ClinicalTrials.gov

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