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

Tracking Information

First Received Date ^ICMJE

November 25, 2008

Last Updated Date

December 2, 2008

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

June 2011 (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

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Polycystic Kidney

Intervention ^ICMJE

Drug: tripterygium wilfordii
Drug: Emodin
Drug: Losartan

Study Arms / Comparison Groups

Experimental: Losartan

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (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 ID ^ICMJE

NCT00801268

Responsible Party

Research Institute of Nephrology, Jinling Hospital,Jinling Hospital,, Research Institute of Nephrology, Jinling Hospital,Jinling Hospital,

Study ID Numbers ^ICMJE

NJCT-0802

Study Sponsor ^ICMJE

Nanjing University School of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Liu Zhihong, Master

Research Institute of Nephrology, Jinling Hospital

Information Provided By

Nanjing University School of Medicine

Verification Date

November 2008

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