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

This study has been terminated.
(high rate of drop-out)
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
First received: November 25, 2008
Last updated: March 27, 2015
Last verified: March 2015
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:

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
Other Name: Frangula emodin,Frangulic acid
Experimental: Triptolide Woldifii
Drug: tripterygium wilfordii

Detailed Description:

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

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

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.
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
Kidney Diseases, Cystic
Urologic Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antispermatogenic Agents
Contraceptive Agents
Contraceptive Agents, Male
Enzyme Inhibitors
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016