Chronic Renal FailurePHARMACO-$NCT02374372
Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit
A study testing conventional hemodialysis and hemodiafiltration On-line in people with Chronic Renal Failure and Hemodialysis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Hemodialysis
- What is being tested?
- conventional hemodialysis and hemodiafiltration On-line
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- more than 18 years old,
- able to consent,
- patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)
Who cannot join
- severe none compliance (often missing sessions without good reasons),
- life expectation less than 3 months,
- treated with high-flux filters in the last 6 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec, H2X 3J4
About this study
Official title: Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit
The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters.
Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).
Read more
Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study.
Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds.
All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.
- Conditions
- Chronic Renal Failure, Hemodialysis
- Being tested
- conventional hemodialysis, hemodiafiltration On-line
- Keywords
- hemodialysis, beta microglobulin, amyloidosis
- Medical subject headings
- Kidney Failure, Chronic, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional hemodialysisDevice
hemodiafiltration On-lineDevice
| Study group | Role | What they receive |
|---|---|---|
| conventional hemodialysis | Active comparator | conventional hemodialysis Receives: Device: conventional hemodialysis |
| hemodiafiltration On-line | Active comparator | hemodiafiltration On-line Receives: Device: hemodiafiltration On-line |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the medication cost between the 2 groups (HD and HDF)
Measured: 3 years
demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group
Measured: 3 years
demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group
Measured: 3 years
Secondary outcomes (4)
demonstrate lower need of Erythropoietin and best control of anemia in HDF
Measured: 3 years
demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF
Measured: 3 years
demonstrate less hospitalization stay and cost related in HDF group
Measured: 3 years
stabilisation or regression of left ventricular hypertrophy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374372
- Sponsor's protocol ID
- CE10.253
- Acronym
- PHARMACO-$
- Status last verified
- Dec 2022
- First submitted
- 24 Sep 2013
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit
- ClinicalTrials.gov ID
- NCT02374372
- Acronym / sponsor ID
- PHARMACO-$ / CE10.253
- Conditions
- Chronic Renal Failure, Hemodialysis
- Keywords
- hemodialysis, beta microglobulin, amyloidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Feb 2015 (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.
The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters.
Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).
Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study.
Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds.
All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional hemodialysis | Active comparator | Device: conventional hemodialysisconventional hemodialysis |
| hemodiafiltration On-line | Active comparator | Device: hemodiafiltration On-linehemodiafiltration On-line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more than 18 years old,
- able to consent,
- patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)
Key exclusion criteria (3 listed)
- severe none compliance (often missing sessions without good reasons),
- life expectation less than 3 months,
- treated with high-flux filters in the last 6 months
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 hemodialysis | Device | conventional hemodialysis |
| hemodiafiltration On-line | Device | hemodiafiltration On-line |
Primary outcome
compare the medication cost between the 2 groups (HD and HDF)
Time frame: 3 years
demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group
Time frame: 3 years
demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group
Time frame: 3 years
4 secondary outcomes
demonstrate lower need of Erythropoietin and best control of anemia in HDF
Time frame: 3 years
demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF
Time frame: 3 years
demonstrate less hospitalization stay and cost related in HDF group
Time frame: 3 years
stabilisation or regression of left ventricular hypertrophy
Time frame: 3 years
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 8 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional hemodialysis and hemodiafiltration On-line in people with Chronic Renal Failure and Hemodialysis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 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 8 Dec 2022. 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 Canada. 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?
compare the medication cost between the 2 groups (HD and HDF) (time frame: 3 years). The study lists 3 primary outcomes in all. 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 8 Dec 2022.