End Stage Renal DiseaseNCT00417105
Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
An observational study of End Stage Renal Disease, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 2 countries.
Trial summary
Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2006to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Maintenance hemodialysis patients
Who may be able to join
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Who cannot join
- No consent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
Monash Medical Centre
Clayton, Victoria, 3168
Geelong Hospital
Geelong, Victoria, 3220
Belgium2 sites
Virga Jesse Ziekenhuis
Hasselt, Limburg, 3500
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.
In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.
Read more
Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).
It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.
The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.
- Conditions
- End Stage Renal Disease
- Being tested
- hemodialysis
- Keywords
- hemodialysis, dialysis adequacy, chronic kidney disease
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysisProcedure or surgery
group 1: twice weekly, four hours
hemodialysisProcedure or surgery
group 2: twice weekly, eight hours
hemodialysisProcedure or surgery
group 3: every other day, eight hours
hemodialysisProcedure or surgery
group 4: six days a week, eight hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | hemodialysis twice weekly 4 hours Receives: Procedure: hemodialysis | |
| 2 | nocturnal dialysis twice weekly 8 hours Receives: Procedure: hemodialysis | |
| 3 | nocturnal hemodialysis, 8 hours every other night Receives: Procedure: hemodialysis | |
| 4 | nocturnal hemodialysis, 8 hours, six times per week Receives: Procedure: hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
removal of protein-bound retention solutes
Measured: 1 dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Björn KI Meijers, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenPieter Evenepoel, MD, PhD, Study director, Universitaire Ziekenhuizen KU LeuvenTom Dejagere, MD, Principal investigator, Virga Jesse ZiekenhuisNigel Toussaint, MD, Principal investigator, Geelong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417105
- Sponsor's protocol ID
- NHD001
- Status last verified
- Mar 2009
- First submitted
- 28 Dec 2006
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.
PubMed 16421516Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.
PubMed 12148107Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
PubMed 15086951
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
- ClinicalTrials.gov ID
- NCT00417105
- Acronym / sponsor ID
- NHD001
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, dialysis adequacy, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Dec 2006 (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.
Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.
In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.
Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).
It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.
The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: hemodialysishemodialysis twice weekly 4 hours |
| 2 | – | Procedure: hemodialysisnocturnal dialysis twice weekly 8 hours |
| 3 | – | Procedure: hemodialysisnocturnal hemodialysis, 8 hours every other night |
| 4 | – | Procedure: hemodialysisnocturnal hemodialysis, 8 hours, six times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Maintenance hemodialysis patients
Key inclusion criteria (3 listed)
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Key exclusion criteria (1 listed)
- No 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 |
|---|---|---|
| hemodialysisgroup 1: twice weekly, four hours | Procedure or surgery | 1 |
| hemodialysisgroup 2: twice weekly, eight hours | Procedure or surgery | 2 |
| hemodialysisgroup 3: every other day, eight hours | Procedure or surgery | 3 |
| hemodialysisgroup 4: six days a week, eight hours | Procedure or surgery | 4 |
Primary outcome
removal of protein-bound retention solutes
Time frame: 1 dialysis session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2009.
- Background: PubMed 16421516Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.
- Background: PubMed 12148107Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.
- Background: PubMed 15086951Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
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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.
Björn KI Meijers, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Pieter Evenepoel, MD, PhD study director
Universitaire Ziekenhuizen KU Leuven
Tom Dejagere, MD principal investigator
Virga Jesse Ziekenhuis
4 sites in 2 countries: 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 Universitaire Ziekenhuizen KU Leuven at 4 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 5 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
removal of protein-bound retention solutes (time frame: 1 dialysis session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417105, which also lists 3 linked publications.
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 5 Mar 2009.