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

This study is currently recruiting participants.

Verified January 2012 by National Taiwan University Hospital

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01503645

First received: January 2, 2012

Last updated: November 12, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2012

Last Updated Date

November 12, 2012

Start Date ^ICMJE

May 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01503645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

People who use Chinese herb

Condition ^ICMJE

Kidney Diseases

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01503645

Other Study ID Numbers ^ICMJE

9461701139, 95D010

Has Data Monitoring Committee

Not Provided

Responsible Party

National Taiwan University Hospital

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Kwan-Dun Wu, MD, PhD

National Taiwan University Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top