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

This study has been terminated.

(high rate of drop-out)

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 27, 2015

Last verified: March 2015

History of Changes

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

MedlinePlus related topics: Kidney Diseases

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 ]


Enrollment:	300
Study Start Date:	November 2008
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

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

Detailed Description:

Randomized

Eligibility


Ages Eligible for Study:	15 Years to 70 Years (Child, Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


China, Jiangsu
Liu ZH, Yao XD,Chen X,Hu YL
Nanjing, Jiangsu, China, 210002
Yao Xiaodan
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Zhi-Hong Liu, M.D.

Investigators


Principal Investigator:	Liu Zhihong, Master	Research Institute of Nephrology, Jinling Hospital

More Information


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:	March 27, 2015
Health Authority:	China: 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 Triptolide Emodin Antispermatogenic Agents Physiological Effects of Drugs Contraceptive Agents, Male Contraceptive Agents	Reproductive Control Agents Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cathartics Gastrointestinal Agents Protein Kinase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016

To Top