NCT00801268

Brief Summary

Triptolide has been approve effective in animal model.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

November 25, 2008

Last Update Submit

March 27, 2015

Conditions

Polycystic Kidney

Keywords

polycystic kidney diseasetripterygium wilfordii

Outcome Measures

Primary Outcomes (1)

  • MRI calculated kidney volume, eGFR

    Every 3-6months

Secondary Outcomes (1)

  • End-stage kidney disease (ESRD)

    every 2months

Study Arms (2)

emodin

ACTIVE COMPARATOR
Drug: Emodin

Triptolide Woldifii

EXPERIMENTAL

TW60mg/d

Drug: tripterygium wilfordii

Interventions

tripterygium wilfordiiDRUG

TW，60mg/d

Triptolide Woldifii
EmodinDRUG

100mg/d

Also known as: Frangula emodin,Frangulic acid
emodin

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Uncontrolled infections
  • Non-ADPKD complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liu ZH, Yao XD,Chen X,Hu YL

Nanjing, Jiangsu, 210002, China

Location

Yao Xiaodan

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases

Interventions

Emodin

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Liu Zhihong, Master

    Research Institute of Nephrology, Jinling Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 25, 2008

First Posted

December 3, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

CN(2)