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

This study is currently recruiting participants.

Verified by Nanjing University School of Medicine, November 2008

First Received: November 25, 2008 Last Updated: December 2, 2008 History of Changes

Sponsor:	Nanjing University School of Medicine
Information provided by:	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 Drug: Losartan

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

Drug Information available for: Losartan Losartan potassium

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:

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

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Drug: Experimental Losartan	Drug: tripterygium wilfordii TW，60mg/d Drug: Emodin Emodin Drug: Losartan 100mg/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

Nanjing University School of Medicine

Investigators

Principal Investigator:

Liu Zhihong, Master

Research Institute of Nephrology, Jinling Hospital

More Information

No publications provided

Responsible Party:	Research Institute of Nephrology, Jinling Hospital,Jinling Hospital, ( Research Institute of Nephrology, Jinling Hospital,Jinling Hospital, )
Study ID Numbers:	NJCT-0802
Study First Received:	November 25, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801268 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Polycystic Kidney, Autosomal Dominant
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Cathartics
Reproductive Control Agents
Contraceptive Agents, Male
Protein Kinase Inhibitors
Urologic Diseases
Triptolide
Therapeutic Uses
Antispermatogenic Agents
Anti-Arrhythmia Agents

Kidney Diseases
Alkylating Agents
Losartan
Kidney Diseases, Cystic
Gastrointestinal Agents
Polycystic Kidney Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Immunosuppressive Agents
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Emodin
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 30, 2009