Peritoneal FibrosisNCT00173056
The Factors Predicting Change of Peritoneal Transport Characters in Peritoneal Dialysate
An observational study of Peritoneal Fibrosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal Fibrosis
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All PD patients
Who cannot join
- Peritonitis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jenq-Wen Huang, MD, 886-2-23123456 ext. 3924, jenqwen@ha.mc.ntu.edu.tw
About this study
Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually ultrafiltration failure. This phenomena will result in technique failure.
High glucose content of the dialysate and peritonitis have been claimed as major stimulants to the development of PF. In each episode of peritonitis, the number of HPMC will decrease. On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted by the white cells or HPMC per se. High glucose dialysate will induce the above process with more chronic stimulation, and PF followed by technique failure is inevitable.
Read more
Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is inconvenient for most patients. Besides, pathology changes will be noted only after a substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually used as the index of peritoneal function. However, in the chronic process, PET change is also slow and is unable to be a parameter for treatment outcome. In this study, the factors predicting PET change will be searched, and they could be an index for evaluation and even a marker of preventing or treating PF.
In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will be measured include vasculoendothelial growth factor, hyaluronan, transforming growth factor-β, procollagen, and cancer antigen-125. The same test and measurement will be performed during PET in the next year. The factors which affect PET results will be analyzed such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The investigators will try to find a convenient acute reactive marker for preventing or treating PF to monitor the PET change clinically.
- Conditions
- Peritoneal Fibrosis
- Keywords
- Peritoneal dialysis
- Medical subject headings
- Peritoneal Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal FibrosisStudies 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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jenq-Wen Huang, MD, Principal investigator, Department of Internal Medicine, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173056
- Sponsor's protocol ID
- 9361700731
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 26 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Factors Predicting Change of Peritoneal Transport Characters in Peritoneal Dialysate
- ClinicalTrials.gov ID
- NCT00173056
- Acronym / sponsor ID
- 9361700731
- Conditions
- Peritoneal Fibrosis
- Keywords
- Peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- First posted
- 15 Sep 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.
Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually ultrafiltration failure. This phenomena will result in technique failure.
High glucose content of the dialysate and peritonitis have been claimed as major stimulants to the development of PF. In each episode of peritonitis, the number of HPMC will decrease. On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted by the white cells or HPMC per se. High glucose dialysate will induce the above process with more chronic stimulation, and PF followed by technique failure is inevitable.
Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is inconvenient for most patients. Besides, pathology changes will be noted only after a substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually used as the index of peritoneal function. However, in the chronic process, PET change is also slow and is unable to be a parameter for treatment outcome. In this study, the factors predicting PET change will be searched, and they could be an index for evaluation and even a marker of preventing or treating PF.
In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will be measured include vasculoendothelial growth factor, hyaluronan, transforming growth factor-β, procollagen, and cancer antigen-125. The same test and measurement will be performed during PET in the next year. The factors which affect PET results will be analyzed such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The investigators will try to find a convenient acute reactive marker for preventing or treating PF to monitor the PET change clinically.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All PD patients
Key exclusion criteria (1 listed)
- Peritonitis
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 26 Nov 2007.
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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.
Jenq-Wen Huang, MD principal investigator
Department of Internal Medicine, NTUH
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 Peritoneal Fibrosis, 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 26 Nov 2007. 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 Jenq-Wen Huang, MD (886-2-23123456 ext. 3924, jenqwen@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 26 Nov 2007.