Randomized Clinical Trial of Triptolide Woldifii for Auto... | NCT00801268

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

NCT00801268

Sponsor

Zhi-Hong Liu, M.D.

Status

Terminated

Last Update Posted

Mar 30, 2015Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Polycystic Kidney

Interventions

tripterygium wilfordii
Emodin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

high rate of drop-out

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2015

Last Update Posted Date

Mar 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
emodin	Active Comparator		Drug: Emodin
Triptolide Woldifii	Experimental	TW60mg/d	Drug: tripterygium wilfordii

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tripterygium wilfordii	Drug	TW，60mg/d	Triptolide Woldifii
Emodin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Uncontrolled infections
Non-ADPKD complications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liu Zhihong, Master	Research Institute of Nephrology, Jinling Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liu ZH, Yao XD,Chen X,Hu YL		Nanjing	Jiangsu	210002	China
Yao Xiaodan

Condition Browse Module

MeSH Terms

ID	Term
D007690	Polycystic Kidney Diseases

Ancestor Terms

ID	Term
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004642	Emodin

Ancestor Terms

ID	Term
D000880	Anthraquinones
D000095322	Anthrones
D000873	Anthracenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided