Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TWH for the treatment of IgAN | Experimental | 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. |
|
| MMF for IgAN | Active Comparator | MMF for the treatment of IgAN for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal survival | Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | liver function test result abnormalities;menstrual disturbance | one year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youming Peng, M.D | Contact | 8615802604114 |
| Name | Affiliation | Role |
|---|---|---|
| Shenghua Zhou, MD | the second xiangya hospital of CSU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Xiangya Hospital of CSU | Recruiting | Changsha | Hunan | 410011 | China |
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mycophenolate mofetil (MMF) | Drug | Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |