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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
* Drug: Mycophenolate mofetil (MMF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: TWH for the treatment of IgAN<br>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. | Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)<br>* 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.<br>* Other names: Multi-glycoside of Tripterygium Wilfordii HOOK. f.;|
| Active Comparator: MMF for IgAN<br>MMF for the treatment of IgAN for 6 months | Drug: Mycophenolate mofetil (MMF)<br>* Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months<br>* Other names: Mycophenolate mofetil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal survival | Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycophenolate mofetil, Tripterygium Wilfordii HOOK. f.