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

Central South University

Status and phase: Unknown; Phase 3

Conditions: IgA Nephropathy

Treatments: Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH); Drug: Mycophenolate mofetil (MMF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02187900

HNXY201401

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

TWH for the treatment of IgAN

Experimental group

Description:

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.

Treatment:

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

MMF for IgAN

Active Comparator group

Description:

MMF for the treatment of IgAN for 6 months

Treatment:

Drug: Mycophenolate mofetil (MMF)