Back to resultsRandomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
Primary Purpose
Polycystic Kidney
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tripterygium wilfordii
Emodin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Kidney focused on measuring polycystic kidney disease, tripterygium wilfordii
Eligibility Criteria
Inclusion Criteria:
- Clinically established ADPKD
- eGFR>30ml/min.
- Chinese nationality
Exclusion Criteria:
- Uncontrolled infections
- Non-ADPKD complications
Sites / Locations
- Liu ZH, Yao XD,Chen X,Hu YL
- Yao Xiaodan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
emodin
Triptolide Woldifii
Arm Description
TW60mg/d
Outcomes
Primary Outcome Measures
MRI calculated kidney volume, eGFR
Secondary Outcome Measures
End-stage kidney disease (ESRD)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00801268
Brief Title
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
Official Title
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
high rate of drop-out
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Triptolide has been approve effective in animal model.
Detailed Description
Randomized
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney
Keywords
polycystic kidney disease, tripterygium wilfordii
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
emodin
Arm Type
Active Comparator
Arm Title
Triptolide Woldifii
Arm Type
Experimental
Arm Description
TW60mg/d
Intervention Type
Drug
Intervention Name(s)
tripterygium wilfordii
Intervention Description
TW，60mg/d
Intervention Type
Drug
Intervention Name(s)
Emodin
Other Intervention Name(s)
Frangula emodin,Frangulic acid
Intervention Description
100mg/d
Primary Outcome Measure Information:
Title
MRI calculated kidney volume, eGFR
Time Frame
Every 3-6months
Secondary Outcome Measure Information:
Title
End-stage kidney disease (ESRD)
Time Frame
every 2months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically established ADPKD
eGFR>30ml/min.
Chinese nationality
Exclusion Criteria:
Uncontrolled infections
Non-ADPKD complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Zhihong, Master
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liu ZH, Yao XD,Chen X,Hu YL
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Yao Xiaodan
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
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