End-Stage Renal DiseasePhase 4NCT00155363
Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis
A Phase 4 study testing conventional artificial kidney (AK) vs. high flux AK in people with End-Stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- conventional artificial kidney (AK) vs. high flux AK
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2004to not given
- Phase
- Phase 4
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired
Who cannot join
- Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Douliu
Pei-Lun Chu, MD, MMS, plchu@ha.mc.ntu.edu.tw
Pei-Lun Chu, MD, MMS
About this study
Official title: The Impact of Conventional Hemodialysis, High Flux Hemodialysis and Hemodiafiltration on Adiponectin, Vascular Function and Clinical Prognosis
Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing hemodialysis. Adiponectin levels were inversely related to body mass index values, plasma leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment index values. In addition to it's ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. In patients with ESRD, renal replacement method was either peritoneal dialysis or HD. High efficient dialysis methods such as high flux HD and HDF had been used more and more popularly. High flux HD and HDF have the advantages in middle to large molecule removal, and better hemodynamic stability. Better clinical prognosis has been shown in patients undergoing high flux HD or HDF. Although studies have demonstrated that the plasma adiponectin levels were elevated in patients receiving HD, whether different dialysis modality will interfere the plasma adiponectin levels and patients' prognosis remain unknown. The current project is planned to investigate the effects of different HD modality on the plasma adiponectin levels and its correlation other serum inflammatory markers and vascular function. Patients' long term prognosis will also be assessed in the present study.
Read the detailed description
Adiponectin, a cytokine with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance (Horm Metab Res 34:469-474, 2002). The plasma adiponectin level has been reported to be decreased in some insulin-resistant states, such as obesity and type 2 diabetes (Biochem Biophys Res Commun 257:79-83, 1999), and coronary artery disease (CAD). However, it is shown to increase in chronic renal failure and type 1 diabetes. (European Journal of Endocrinology 148;293-300, 2003). Plasma adiponectin levels were inversely related to body mass index values, plasma leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment index values (J Am Soc Nephrol 13:134-141, 2002, Clin Sci 103:137-142, 2002, Arterioscler Thromb Vasc Biol 20:1595-1599, 2000, Diabetes 52:942-947, 2003). In addition to it's ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. (European Journal of Endocrinology 148;293-300, 2003, J Hypertens 18:1207-1213, 2000). It is also associated with vascular function independent of insulin sensitivity (Diabetes Care 27:739-745, 2004). In patients with ESRD, CAD remained the leading cause of death (Kidney Int 62:1417-1422, 2002) regardless of different renal replacement methods (peritoneal dialysis or HD) and the modality it uses. In recent years, with the development of high flux HD and HDF, the dialyzer has gained much progress in its efficiency. High flux HD and HDF have the advantages in middle to large molecule removal and better hemodynamic stability (Kidney Int. 66:355-66, 2004). Adiponectin, a large molecule (30kd), was not removed readily by conventional HD (Am J Kidney Dis 43:1047-1055, 2004), but it might be removed by high flux and HDF.
Due to undialyzable characteristic and decreased excretion from impaired renal function (Am J Kidney Dis 43:1047-1055, 2004, Circulation 100:2473-2476, 1999), adiponectin level is elevated in patients receiving HD and PD. Adiponectin has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing HD (J Am Soc Nephrol 13:134-141, 2002) or PD (Am J Kidney Dis 43:1047-1055, 2004). Weather the elevation of adiponectin level is a protective factor of cardiovascular risk or just a reactor from inflammatory condition remains unknown. This project was aimed to study the removal efficiency of adiponectin in high flux HD and HDF and also the consequence of long term prognosis. Besides, other metabolic and inflammatory markers such as CRP, homocystine, insulin, interleukin group will be measured. Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. So this project was aimed to study:
- The removal efficiency of adiponectin in different hemodialysis modality.
- To figure out the role of adiponectin in ESRD patients: a protective or an inflammation marker.
- Patients' long term prognosis will be analyzed.
- Other metabolic and inflammatory markers such as CRP, homocystine, insulin, interleukin group and their relationship with adiponectin will be investigated.
- Vascular function will be assessed and its correlation with adiponectin levels will be studied.
- Conditions
- End-Stage Renal Disease
- Being tested
- conventional artificial kidney (AK) vs. high flux AK
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional artificial kidney (AK) vs. high flux AKDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiponectin and inflammatory cytokines level
Secondary outcomes (1)
Cardiovascular event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, MD, PhD, Study director, National Taiwan University HospitalPei-Lun Chu, MD, MMS, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155363
- Sponsor's protocol ID
- 9361701293
- Status last verified
- Jun 2005
- First submitted
- 8 Sep 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Conventional Hemodialysis, High Flux Hemodialysis and Hemodiafiltration on Adiponectin, Vascular Function and Clinical Prognosis
- ClinicalTrials.gov ID
- NCT00155363
- Acronym / sponsor ID
- 9361701293
- Conditions
- End-Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 12 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.
Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing hemodialysis. Adiponectin levels were inversely related to body mass index values, plasma leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment index values. In addition to it's ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. In patients with ESRD, renal replacement method was either peritoneal dialysis or HD. High efficient dialysis methods such as high flux HD and HDF had been used more and more popularly. High flux HD and HDF have the advantages in middle to large molecule removal, and better hemodynamic stability. Better clinical prognosis has been shown in patients undergoing high flux HD or HDF. Although studies have demonstrated that the plasma adiponectin levels were elevated in patients receiving HD, whether different dialysis modality will interfere the plasma adiponectin levels and patients' prognosis remain unknown. The current project is planned to investigate the effects of different HD modality on the plasma adiponectin levels and its correlation other serum inflammatory markers and vascular function. Patients' long term prognosis will also be assessed in the present study.
Detailed description
Adiponectin, a cytokine with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance (Horm Metab Res 34:469-474, 2002). The plasma adiponectin level has been reported to be decreased in some insulin-resistant states, such as obesity and type 2 diabetes (Biochem Biophys Res Commun 257:79-83, 1999), and coronary artery disease (CAD). However, it is shown to increase in chronic renal failure and type 1 diabetes. (European Journal of Endocrinology 148;293-300, 2003). Plasma adiponectin levels were inversely related to body mass index values, plasma leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment index values (J Am Soc Nephrol 13:134-141, 2002, Clin Sci 103:137-142, 2002, Arterioscler Thromb Vasc Biol 20:1595-1599, 2000, Diabetes 52:942-947, 2003). In addition to it's ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. (European Journal of Endocrinology 148;293-300, 2003, J Hypertens 18:1207-1213, 2000). It is also associated with vascular function independent of insulin sensitivity (Diabetes Care 27:739-745, 2004). In patients with ESRD, CAD remained the leading cause of death (Kidney Int 62:1417-1422, 2002) regardless of different renal replacement methods (peritoneal dialysis or HD) and the modality it uses. In recent years, with the development of high flux HD and HDF, the dialyzer has gained much progress in its efficiency. High flux HD and HDF have the advantages in middle to large molecule removal and better hemodynamic stability (Kidney Int. 66:355-66, 2004). Adiponectin, a large molecule (30kd), was not removed readily by conventional HD (Am J Kidney Dis 43:1047-1055, 2004), but it might be removed by high flux and HDF.
Due to undialyzable characteristic and decreased excretion from impaired renal function (Am J Kidney Dis 43:1047-1055, 2004, Circulation 100:2473-2476, 1999), adiponectin level is elevated in patients receiving HD and PD. Adiponectin has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing HD (J Am Soc Nephrol 13:134-141, 2002) or PD (Am J Kidney Dis 43:1047-1055, 2004). Weather the elevation of adiponectin level is a protective factor of cardiovascular risk or just a reactor from inflammatory condition remains unknown. This project was aimed to study the removal efficiency of adiponectin in high flux HD and HDF and also the consequence of long term prognosis. Besides, other metabolic and inflammatory markers such as CRP, homocystine, insulin, interleukin group will be measured. Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. So this project was aimed to study:
- The removal efficiency of adiponectin in different hemodialysis modality.
- To figure out the role of adiponectin in ESRD patients: a protective or an inflammation marker.
- Patients' long term prognosis will be analyzed.
- Other metabolic and inflammatory markers such as CRP, homocystine, insulin, interleukin group and their relationship with adiponectin will be investigated.
- Vascular function will be assessed and its correlation with adiponectin levels will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired
Key exclusion criteria (1 listed)
- Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional artificial kidney (AK) vs. high flux AK | Device | – |
Primary outcome
Adiponectin and inflammatory cytokines level
1 secondary outcome
Cardiovascular event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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 director
National Taiwan University Hospital
Pei-Lun Chu, MD, MMS 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?
A Phase 4 study testing conventional artificial kidney (AK) vs. high flux AK in people with 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 20 Dec 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (0933124808, plchu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adiponectin and inflammatory cytokines level. 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 20 Dec 2005.