A Study of Drug-Induced Kidney Disease

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, May 2008

Sponsors and Collaborators:	National Taiwan University Hospital Department of Health, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00729014

Purpose

The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center

Condition
End Stage Renal Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
Official Title:	A Study of Drug-Induced Kidney Disease

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

The incidence of herbal nephropathy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The epidemiology of primary diagnosis for end stage renal disease in Taiwan [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	May 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This is a retrospective study, by computer screening, chart review and phone survey to find herbal nephropathy and determine the cause-relationship.

Using ICD-9-CM code as a tool to screen the newly diagnosed ESRD in NTUH computer data base, and divided patients into those with underlying disease(s) that cause the renal failure and those without.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

a medical center

Criteria

Inclusion Criteria:

patient who was newly diagnosed as end stage renal disease who need dialysis

Exclusion Criteria:

started dialysis before 2000

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729014

Contacts

Contact: Fe-Lin L Wu, MSCP, Ph.D	886-2-23123456 ext 8389	flwu@ntu.edu.tw
Contact: Kwan-Dun Wu, MD, Ph.D	886-2-23123456 ext 5014	kdwu@ntuh.gov.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Fe-Lin L. Wu, MSCP,Ph D +886-2-23123456 ext 8389 flwu@ntu.edu.tw
Contact: Kwan-Dun Wu, MD, PhD +886-2-23123456 ext 5014 kdwu@ntuh.gov.tw
Principal Investigator: Fe-Lin L. Wu, Ph D

Sponsors and Collaborators

National Taiwan University Hospital

Department of Health, Taiwan

Investigators

Principal Investigator:

Kwan-Dun Wu, MD, PhD

National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital ( Fe-Lin L Wu, Ph.D., Director )
Study ID Numbers:	200804062R
Study First Received:	August 1, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00729014
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

herbal nephropathy
Chinese herbal nephropathy
nephrotoxicity

renal disease
adverse drug reaction
Chinese herbal medicine

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 13, 2009