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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
Sponsor:
Information provided by (Responsible Party):
Youming Peng, Second Xiangya Hospital of Central South University

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

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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
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




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



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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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Youming Peng, M.D 8615802604114

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

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Responsible Party: Youming Peng, Director of the Nephrology Institute, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02187900     History of Changes
Other Study ID Numbers: HNXY201401
First Posted: July 11, 2014    Key Record Dates
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:
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Glomerulonephritis, IGA
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
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