Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease

This study is currently recruiting participants.

Verified March 2013 by Nanjing University School of Medicine

Sponsor:

Information provided by (Responsible Party):

Zhi-Hong Liu, M.D., Nanjing University School of Medicine

ClinicalTrials.gov Identifier:

NCT00801268

First received: November 25, 2008

Last updated: March 29, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2008

Last Updated Date

March 29, 2013

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MRI calculated kidney volume, eGFR [ Time Frame: Every 3-6months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00801268 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

End-stage kidney disease (ESRD) [ Time Frame: every 2months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

ESRD [ Time Frame: every 2months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease

Official Title ^ICMJE

Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Brief Summary

Triptolide has been approve effective in animal model.

Detailed Description

Randomized

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Polycystic Kidney

Intervention ^ICMJE

Drug: tripterygium wilfordii
TW，60mg/d
Drug: Emodin
100mg/d

Other Name: Frangula emodin,Frangulic acid

Study Arm (s)

Active Comparator: emodin
Intervention: Drug: Emodin
Experimental: Triptolide Woldifii
TW60mg/d

Intervention: Drug: tripterygium wilfordii

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

September 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinically established ADPKD
eGFR>30ml/min.
Chinese nationality

Exclusion Criteria:

Uncontrolled infections
Non-ADPKD complications

Gender

Both

Ages

15 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yao Xiaodan, Master

00862586030066

yaoxiaodan@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00801268

Other Study ID Numbers ^ICMJE

NJCT-0802

Has Data Monitoring Committee

Yes

Responsible Party

Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Study Sponsor ^ICMJE

Zhi-Hong Liu, M.D.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Liu Zhihong, Master

Research Institute of Nephrology, Jinling Hospital

Information Provided By

Nanjing University School of Medicine

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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