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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
  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:

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 2013
Estimated Primary Completion Date: June 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
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: March 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
polycystic kidney disease
tripterygium wilfordii

Additional relevant MeSH terms:
Triptolide
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Emodin
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 June 18, 2013