Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
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ClinicalTrials.gov Identifier: NCT02187900 |
Recruitment Status : Unknown
Verified July 2014 by Youming Peng, Second Xiangya Hospital of Central South University.
Recruitment status was: Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
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Condition or disease | Intervention/treatment | Phase |
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IgA Nephropathy | Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) Drug: Mycophenolate mofetil (MMF) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | August 2015 |
Estimated Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
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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.
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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.
Other Name: Multi-glycoside of Tripterygium Wilfordii HOOK. f. |
Active Comparator: MMF for IgAN
MMF for the treatment of IgAN for 6 months
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Drug: Mycophenolate mofetil (MMF)
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
Other Name: Mycophenolate mofetil |
- 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
- Renal survival [ Time Frame: one year ]Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.
- adverse event [ Time Frame: one year ]liver function test result abnormalities;menstrual disturbance

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187900
Contact: Youming Peng, M.D | 8615802604114 |
China, Hunan | |
The second Xiangya Hospital of CSU | Recruiting |
Changsha, Hunan, China, 410011 | |
Contact: Liyu He, M.D 8615802604114 heliyu1124@126.com | |
Principal Investigator: Liyu He, M.D |
Study Director: | Shenghua Zhou, MD | the second xiangya hospital of CSU |
Responsible Party: | Youming Peng, Director of the Nephrology Institute, Second Xiangya Hospital of Central South University |
ClinicalTrials.gov Identifier: | NCT02187900 |
Other Study ID Numbers: |
HNXY201401 |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | July 11, 2014 |
Last Verified: | July 2014 |
Tripterygium Wilfordii HOOK. f. Mycophenolate mofetil |
Glomerulonephritis, IGA Kidney Diseases Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Mycophenolic Acid Cardiac Glycosides Antibiotics, Antineoplastic Antineoplastic Agents |
Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Cardiotonic Agents Protective Agents Physiological Effects of Drugs |