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

March 27, 2015 updated by: Zhi-Hong Liu, M.D.

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

Triptolide has been approve effective in animal model.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically established ADPKD
  • eGFR>30ml/min.
  • Chinese nationality

Exclusion Criteria:

  • Uncontrolled infections
  • Non-ADPKD complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: emodin
Drug: Emodin
100mg/d
Other Names:
  • Frangula emodin,Frangulic acid
EXPERIMENTAL: Triptolide Woldifii
TW60mg/d
Drug: tripterygium wilfordii
TW，60mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI calculated kidney volume, eGFR
Time Frame: Every 3-6months
Every 3-6months

Secondary Outcome Measures

Outcome Measure
Time Frame
End-stage kidney disease (ESRD)
Time Frame: every 2months
every 2months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhi-Hong Liu, M.D.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Kidney

Clinical Trials on Emodin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe