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

NCT ID: NCT02187900

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-09-30

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.

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

Conditions

IgA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

MMF for IgAN

MMF for the treatment of IgAN for 6 months

Group Type: ACTIVE_COMPARATOR

Mycophenolate mofetil (MMF)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Mycophenolate mofetil (MMF)

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

Intervention Type: DRUG

Other Intervention Names

Multi-glycoside of Tripterygium Wilfordii HOOK. f.; Mycophenolate mofetil

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Youming Peng

Director of the Nephrology Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shenghua Zhou, MD

Role: STUDY_DIRECTOR

the second xiangya hospital of CSU

Locations

The second Xiangya Hospital of CSU

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Youming Peng, M.D

Role: CONTACT

8615802604114

Facility Contacts

Liyu He, M.D

Role: primary

heliyu1124@126.com

8615802604114

Other Identifiers

HNXY201401

Identifier Type: -

Identifier Source: org_study_id