Kidney DiseasesNCT01503645
Chinese Herb Nephropathy Epidemiology and Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism
An observational study of Kidney Diseases, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
1. Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may be related to the a component called aristolochic acid (AA). 2. AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney failure and/or cancer 3. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- May 2006to not given
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People who use Chinese herb
Who may be able to join
- Patient with suspected Chinese herb nephropathy, and their family Control group match for sex age and geographic area (with or without herabla use)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Far Estern Memorial Hospital
Banqiao District, Taipei, 22060
- Recruiting
National Taiwan University Hospital
Taipei, 10051
Kwan-Dun Wu, MD, PhD, +886-2-23123456 ext. 5014, kdw@ntumc.org
Fe-Lin L Wu, Ph.D.
About this study
Official title: Epidemiology of Chinese Herb Nephropathy and Its Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism
- 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.
- Conditions
- Kidney Diseases
- Keywords
- kidney diseases, drugs, Chinese herbal, aristolochic acid, polymorphism, genetic
- Medical subject headings
- Kidney Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- Cross-sectional
- Enrolment
- 200 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)
- Responsible party
- Sponsor
- Investigators
- Kwan-Dun Wu, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503645
- Sponsor's protocol ID
- 9461701139
- Other IDs
- 95D010
- Status last verified
- Jan 2012
- First submitted
- 2 Jan 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Chinese Herb Nephropathy and Its Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism
- ClinicalTrials.gov ID
- NCT01503645
- Acronym / sponsor ID
- 9461701139
- Conditions
- Kidney Diseases
- Keywords
- kidney diseases, drugs, Chinese herbal, aristolochic acid, polymorphism, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- May 2006
- First posted
- 4 Jan 2012 (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.
- 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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who use Chinese herb
Key inclusion criteria (1 listed)
- Patient with suspected Chinese herb nephropathy, and their family Control group match for sex age and geographic area (with or without herabla use)
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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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 study chair
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by National Taiwan University Hospital at 2 sites 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 0 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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, Ph.D. (+886-2-23938231, flwu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 14 Nov 2012.