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

Polycystic Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00801268
• Other study ID #: NJCT-0802
• Status: Terminated
• Phase: N/A
• First received: November 25, 2008
• Last updated: March 27, 2015
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Triptolide has been approve effective in animal model.

Description:

Randomized

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinically established ADPKD

• eGFR>30ml/min.

• Chinese nationality

Exclusion Criteria:

• Uncontrolled infections

• Non-ADPKD complications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

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

Locations

Country	Name	City	State
China	Liu ZH, Yao XD,Chen X,Hu YL	Nanjing	Jiangsu
China	Yao Xiaodan	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI calculated kidney volume, eGFR		Every 3-6months	Yes
Secondary	End-stage kidney disease (ESRD)		every 2months	Yes