Chinese Herb Nephropathy Epidemiology and Association Wit... | NCT01503645

Studies
Chinese Herb Nephropathy Epidemiology and Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism

NCT01503645

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 14, 2012Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Kidney Diseases

Interventions

Not provided

Countries

Taiwan

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

ID	Type	Description	Link
95D010

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 2, 2012

First Submission Date that Met QC Criteria

Jan 3, 2012

First Posted Date

Jan 4, 2012Estimated

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

Nov 12, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Name	Class
Department of Health, Executive Yuan, R.O.C. (Taiwan)	OTHER_GOV

Description Module

Brief Summary

Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may be related to the a component called aristolochic acid (AA).
AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney failure and/or cancer
Different enzymes have been reported to detoxify plant alkaloids or other components. Genes that regulate the production of these metabolic enzymes may affect the chance of CHN.
By comparing the differences in the polymorphisms of these genes between patient with CHN and control, we may find the changes that play a significant genetic factors for CHN.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with suspected Chinese herb nephropathy, and their family Control group match for sex age and geographic area (with or without herabla use)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

People who use Chinese herb

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fe-Lin L Wu, Ph.D.	Contact	+886-2-23938231		flwu@ha.mc.ntu.edu.tw
Kwan-Dun Wu, MD, Ph.D.	Contact	+886-2-23123456	5014	kdw@ntumc.org

Overall Officials

Name	Affiliation	Role
Kwan-Dun Wu, MD, PhD	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Estern Memorial Hospital	Not yet recruiting	Banqiao District	Taipei	22060	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided