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

Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f

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 Overview

• Status: Unknown
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH); Drug: Mycophenolate mofetil (MMF)

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The second Xiangya Hospital of CSU
      • Contact: Liyu He, M.D; Phone Number: 8615802604114; Email: heliyu1124@126.com
      • Principal Investigator: Liyu He, M.D

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Mycophenolate mofetil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal survival	Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event	liver function test result abnormalities;menstrual disturbance	one year

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Study Director: Shenghua Zhou, MD, The second Xiangya Hospital of CSU

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: June 22, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Mycophenolate mofetil; Tripterygium Wilfordii HOOK. f.
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Glomerulonephritis, IGA; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Protective Agents; Cardiotonic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid; Cardiac Glycosides
• Other Study ID Numbers: HNXY201401