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

Overview

Triptolide has been approve effective in animal model.

Full Title of Study: “Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: November 2013

Detailed Description

Randomized

Interventions

• Drug: tripterygium wilfordii
  • TW，60mg/d
• Drug: Emodin
  • 100mg/d

Arms, Groups and Cohorts

• Active Comparator: emodin
• Experimental: Triptolide Woldifii
  • TW60mg/d

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

• Clinically established ADPKD – eGFR>30ml/min. – Chinese nationality Exclusion Criteria:

• Uncontrolled infections – Non-ADPKD complications

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Zhi-Hong Liu, M.D.
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Zhi-Hong Liu, M.D., professor – Nanjing University School of Medicine
• Overall Official(s)
  • Liu Zhihong, Master, Principal Investigator, Research Institute of Nephrology, Jinling Hospital