End-Stage Renal Disease (ESRD)NCT00243958
Aluminum and Auditory Function in ESRD
An observational study of End-Stage Renal Disease (ESRD), run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- End-Stage Renal Disease (ESRD)
- How many people
- 80 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2005to 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ESRD patients and healthy volunteers, without history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect
Who cannot join
- Unsuitable to undergo hearing test, with history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Yun-Lin
Pei-Lun Chu, MD, MMS, 886-5-5320409 ext. 5775, plchu@ha.mc.ntu.edu.tw
Pei-Lun Chu, MD, MMS
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Yun-Lin
Pei-Lun Chu, MD, MMS, 886-5-5320409 ext. 5755, plchu@ha.mc.ntu.edu.tw
About this study
Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. The causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like Alport syndrome or other collagen-defective renal disease, or just aging related. End-stage renal disease (ESRD) patients are special in many parts to general population who have hearing impairment. First, inflammation in ESRD patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself was found to be a cause of hearing impairment, too. The biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to Alzheimer's disease, dementia or some neurologic diseases. Al intoxication is very rare in general health population but elevated serum Al level is easily found in ESRD patients since they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic tissue, so if serum Al level in ESRD patients has any association in their haring function needs to be studied.
- Conditions
- End-Stage Renal Disease (ESRD)
- Medical subject headings
- Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease (ESRD)Studies 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
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, MD. PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243958
- Sponsor's protocol ID
- 9461701003
- Status last verified
- Oct 2005
- First submitted
- 23 Oct 2005
- Last updated
- 25 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aluminum and Auditory Function in ESRD
- ClinicalTrials.gov ID
- NCT00243958
- Acronym / sponsor ID
- 9461701003
- Conditions
- End-Stage Renal Disease (ESRD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 25 Oct 2005 (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.
Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. The causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like Alport syndrome or other collagen-defective renal disease, or just aging related. End-stage renal disease (ESRD) patients are special in many parts to general population who have hearing impairment. First, inflammation in ESRD patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself was found to be a cause of hearing impairment, too. The biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to Alzheimer's disease, dementia or some neurologic diseases. Al intoxication is very rare in general health population but elevated serum Al level is easily found in ESRD patients since they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic tissue, so if serum Al level in ESRD patients has any association in their haring function needs to be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD patients and healthy volunteers, without history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect
Key exclusion criteria (1 listed)
- Unsuitable to undergo hearing test, with history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect
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 25 Oct 2005.
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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 End-Stage Renal Disease (ESRD), 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 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 25 Oct 2005. 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 Pei-Lun Chu, MD,MMS (886-5-5320409 ext. 5755, plchu@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 25 Oct 2005.