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

• ClinicalTrials.gov Identifier: NCT02187900
• Recruitment Status: Unknown
• First Posted: July 11, 2014
• Last Update Posted: July 11, 2014
• Sponsor: Second Xiangya Hospital of Central South University
• Information provided by (Responsible Party): Youming Peng, Second Xiangya Hospital of Central South University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
IgA Nephropathy	Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH); Drug: Mycophenolate mofetil (MMF)	Phase 3

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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	Drug: Mycophenolate mofetil (MMF); Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months; Other Name: Mycophenolate mofetil

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Other Outcome Measures:

1. adverse event [ Time Frame: one year ]
   liver function test result abnormalities;menstrual disturbance

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Youming Peng, M.D; 8615802604114

Locations

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

Sponsors and Collaborators

Second Xiangya Hospital of Central South University

Investigators

• Study Director: Shenghua Zhou, MD; the second xiangya hospital of CSU

More Information

• 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
• Last Update Posted: July 11, 2014
• Last Verified: July 2014

Keywords provided by Youming Peng, Second Xiangya Hospital of Central South University:

Tripterygium Wilfordii HOOK. f.; Mycophenolate mofetil

Additional relevant MeSH terms:

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