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

Primary Purpose

IgA Nephropathy

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
Mycophenolate mofetil (MMF)
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Tripterygium Wilfordii HOOK. f., Mycophenolate mofetil

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The second Xiangya Hospital of CSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TWH for the treatment of IgAN

MMF for IgAN

Arm 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.

MMF for the treatment of IgAN for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Renal survival
Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.

Full Information

First Posted
June 22, 2014
Last Updated
July 10, 2014
Sponsor
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02187900
Brief Title
Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
Official Title
Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Tripterygium Wilfordii HOOK. f., Mycophenolate mofetil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TWH for the treatment of IgAN
Arm Type
Experimental
Arm 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.
Arm Title
MMF for IgAN
Arm Type
Active Comparator
Arm Description
MMF for the treatment of IgAN for 6 months
Intervention Type
Drug
Intervention Name(s)
Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
Other Intervention Name(s)
Multi-glycoside of Tripterygium Wilfordii HOOK. f.
Intervention Description
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
Intervention Name(s)
Mycophenolate mofetil (MMF)
Other Intervention Name(s)
Mycophenolate mofetil
Intervention Description
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
Primary Outcome Measure Information:
Title
Number of patients reaching remission
Description
(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
Time Frame
one year
Secondary Outcome Measure Information:
Title
Renal survival
Description
Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
adverse event
Description
liver function test result abnormalities;menstrual disturbance
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youming Peng, M.D
Phone
8615802604114
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shenghua Zhou, MD
Organizational Affiliation
the second xiangya hospital of CSU
Official's Role
Study Director
Facility Information:
Facility Name
The second Xiangya Hospital of CSU
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyu He, M.D
Phone
8615802604114
Email
heliyu1124@126.com
First Name & Middle Initial & Last Name & Degree
Liyu He, M.D

12. IPD Sharing Statement

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

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