End Stage Renal DiseaseNCT00729014
A Study of Drug-Induced Kidney Disease
An observational study of End Stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: a medical center
Who may be able to join
- patient who was newly diagnosed as end stage renal disease who need dialysis
Who cannot join
- started dialysis before 2000
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Fe-Lin L. Wu, MSCP,Ph D, +886-2-23123456 ext. 8389, flwu@ntu.edu.tw
Kwan-Dun Wu, MD, PhD, +886-2-23123456 ext. 5014, kdwu@ntuh.gov.tw
About this study
The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center
Read the 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.
- Conditions
- End Stage Renal Disease
- Keywords
- herbal nephropathy, Chinese herbal nephropathy, nephrotoxicity, renal disease, adverse drug reaction, Chinese herbal medicine
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of herbal nephropathy
Measured: 5 years
Secondary outcomes (1)
The epidemiology of primary diagnosis for end stage renal disease in Taiwan
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Kwan-Dun Wu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729014
- Sponsor's protocol ID
- 200804062R
- Status last verified
- May 2008
- First submitted
- 1 Aug 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Drug-Induced Kidney Disease
- ClinicalTrials.gov ID
- NCT00729014
- Acronym / sponsor ID
- 200804062R
- Conditions
- End Stage Renal Disease
- Keywords
- herbal nephropathy, Chinese herbal nephropathy, nephrotoxicity, renal disease, adverse drug reaction, Chinese herbal medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- May 2008
- Primary completion
- Sep 2008 (estimated)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- a medical center
Key inclusion criteria (1 listed)
- patient who was newly diagnosed as end stage renal disease who need dialysis
Key exclusion criteria (1 listed)
- started dialysis before 2000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of herbal nephropathy
Time frame: 5 years
1 secondary outcome
The epidemiology of primary diagnosis for end stage renal disease in Taiwan
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwan-Dun Wu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fe-Lin L Wu, MSCP, Ph.D (886-2-23123456 ext. 8389, flwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of herbal nephropathy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.