A Study of Drug-Induced Kidney Disease | NCT00729014

Studies
A Study of Drug-Induced Kidney Disease

NCT00729014

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2008Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

End Stage Renal Disease

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

Status Module

Record Verification Date

May 2008

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 2008

Primary Completion Date

Sep 2008Estimated

Completion Date

Not provided

First Submitted Date

Aug 1, 2008

First Submission Date that Met QC Criteria

Aug 1, 2008

First Posted Date

Aug 6, 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

Aug 1, 2008

Last Update Posted Date

Aug 6, 2008Estimated

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

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

Description Module

Brief Summary

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

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.

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

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of herbal nephropathy		5 years

Secondary Outcomes

Measure	Description	Time Frame
The epidemiology of primary diagnosis for end stage renal disease in Taiwan		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

started dialysis before 2000

Accepts Healthy Volunteers

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

a medical center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fe-Lin L Wu, MSCP, Ph.D	Contact	886-2-23123456	8389	flwu@ntu.edu.tw
Kwan-Dun Wu, MD, Ph.D	Contact	886-2-23123456	5014	kdwu@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Kwan-Dun Wu, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D007674	Kidney Diseases
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided