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

This study is currently recruiting participants.

Verified February 2012 by Nanjing University School of Medicine

First Received on November 25, 2008. Last Updated on February 8, 2012 History of Changes

Sponsor:	Zhi-Hong Liu, M.D.
Information provided by (Responsible Party):	Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00801268

Purpose

Triptolide has been approve effective in animal model.

Condition	Intervention
Polycystic Kidney	Drug: tripterygium wilfordii Drug: Emodin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: emodin	Drug: Emodin 100mg/d
Experimental: Triptolide Woldifii TW60mg/d	Drug: tripterygium wilfordii TW，60mg/d

Detailed Description:

Randomized

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Uncontrolled infections
Non-ADPKD complications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801268

Contacts

Contact: Yao Xiaodan, Master

00862586030066

yaoxiaodan@hotmail.com

Locations

China, Jiangsu
Liu ZH, Yao XD,Chen X,Hu YL	Recruiting
Nanjing, Jiangsu, China, 210002
Contact: XIAO-DAN YAO, Dr. 00862586030066 yaoxiaodan@hotmail.com
Yao Xiaodan	Recruiting
Nanjing, Jiangsu, China, 210002
Contact: XD YAO 00862586030066 yaoxiaodan@hotmail.com

Sponsors and Collaborators

Zhi-Hong Liu, M.D.

Investigators

Principal Investigator:

Liu Zhihong, Master

Research Institute of Nephrology, Jinling Hospital

More Information

No publications provided

Responsible Party:	Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00801268 History of Changes
Other Study ID Numbers:	NJCT-0802
Study First Received:	November 25, 2008
Last Updated:	February 8, 2012
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

polycystic kidney disease
tripterygium wilfordii

Additional relevant MeSH terms:

Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Emodin
Triptolide
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012