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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00801268
Recruitment Status : Terminated (high rate of drop-out)
First Posted : December 3, 2008
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Triptolide has been approve effective in animal model.

Condition or disease Intervention/treatment
Polycystic Kidney Drug: tripterygium wilfordii Drug: Emodin

Detailed Description:
Randomized

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Start Date : November 2008
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. MRI calculated kidney volume, eGFR [ Time Frame: Every 3-6months ]

Secondary Outcome Measures :
  1. End-stage kidney disease (ESRD) [ Time Frame: every 2months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Zhi-Hong Liu, M.D., 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
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
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