Trial record 23 of 94 for:    Polycystic Kidney Disease

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

This study has been terminated.
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: August 30, 2013
Last verified: March 2013
  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:


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
Estimated Study Completion Date: November 2013
Estimated 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
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

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: August 30, 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:
Kidney Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities
Emodin
Triptolide
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 August 21, 2014