End Stage Renal DiseaseNCT01539252
Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients
A study testing Single dialyzer and Two dialyzers in people with End Stage Renal Disease, run by University of Alberta at 2 sites in Canada.
Trial summary
The purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment). 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?
- Single dialyzer and Two dialyzers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Dec 2014
- 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
- Age > 18 years
- Patients must be on a stable regimen of hemodialysis for ≥ 3 months ('stable' defined as not expected to require a change to the duration or frequency of treatments)
- Serum phosphate > 1.6 mmol/l on last two consecutive lab tests at least 3 weeks apart (KDOQI guidelines recommend maintaining predialysis phosphate < 1.8mmol/l - as such, phosphate lowering in this subgroup of patients is particularly relevant)
- Patients must be on stable doses of a phosphate binder with no changes in dose 1 month prior to study enrolment.
- Blood flow rate ≥ 350 ml/min through a well-functioning access (This will exclude patients receiving inadequate dialysis due to a temporary venous dialysis catheter and will ensure sufficient blood flow to permit dialysis using two dialysers in parallel.)
Who cannot join
- Patients who have a scheduled renal transplant, change in dialysis modality, surgery or hospitalization or plan on moving away from the study site in the next three months.
- Patients with a projected life expectancy of less than 3 months.
- Patients with a contraindication to intra-dialytic anticoagulation. (Some patients require a small increase in the amount of anticoagulation required to prevent dialyser clotting when using two dialysers in parallel).
- Patients who have missed >8 dialysis treatments in the past 3 months.
- Patients with a dialysis regimen of >3 runs per week.
- Failure to provide informed consent.
- Patients enrolled in another (interventional) trial
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2V2
About this study
The purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment).
Read the detailed description
Higher levels of serum phosphate are independently associated with an increased risk of death in hemodialysis patients. Therefore, there has been considerable interest in controlling serum phosphate while minimizing oral calcium load. While most attention has focused on the use of non-calcium containing phosphate binders such as sevelamer and lanthanum, modifying conventional dialysis regimens to improve phosphate clearance is an alternative approach that remains relatively unstudied. A secondary analysis of a previous randomized cross-over study from our group found that the use of two dialysers in parallel resulted in a reduction in pre-dialysis serum phosphate levels. As this study was small, and the mechanisms resulting in the reduction in phosphate levels were unclear, further study is warranted. The investigators will conduct a randomized cross-over study comparing the impact of dialyzing using two dialysers in parallel with a single dialyser in hyperphosphatemic hemodialysis patients.
There will be a total of 34 participants from Alberta,Canada participating in this study. The length of study participation is 10 weeks.
- Conditions
- End Stage Renal Disease
- Being tested
- Single dialyzer, Two dialyzers
- Keywords
- hemodialysis, adequacy, phosphate clearance, double dialyzer, two dialyzers in parallel
- 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.
Single dialyzerProcedure or surgery
Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.
Two dialyzersProcedure or surgery
Hemodialysis treatment using a two Baxter dialyzers in parallel.
| Study group | Role | What they receive |
|---|---|---|
| Single dialyzer | Active comparator | Single dialyzer Receives: Procedure: Single dialyzer |
| Double dialyzer | Experimental | Two dialyzers in parallel Receives: Procedure: Two dialyzers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysate clearance of phosphate
Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.
Measured: 3 weeks
Secondary outcomes (2)
Serum phosphate
Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods.
Measured: 3 weeks
Dialysate removal of phosphate
Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of AlbertaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Marcello Tonelli, University of Alberta
- Investigators
- Marcello Tonelli, MD, Principal investigator, University of AlbertaBraden Manns, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539252
- Sponsor's protocol ID
- DDphos1
- Status last verified
- Dec 2016
- First submitted
- 3 Feb 2012
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thompson S, Manns B, Lloyd A, Hemmelgarn B, MacRae J, Klarenbach S, Unsworth L, Courtney M, Tonelli M. Impact of using two dialyzers in parallel on phosphate clearance in hemodialysis patients: a randomized trial. Nephrol Dial Transplant. 2017 May 1;32(5):855-861. doi: 10.1093/ndt/gfw085.
PubMed 27190374
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01539252
- Acronym / sponsor ID
- DDphos1
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, adequacy, phosphate clearance, double dialyzer, two dialyzers in parallel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Feb 2012 (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 purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment).
Detailed description
Higher levels of serum phosphate are independently associated with an increased risk of death in hemodialysis patients. Therefore, there has been considerable interest in controlling serum phosphate while minimizing oral calcium load. While most attention has focused on the use of non-calcium containing phosphate binders such as sevelamer and lanthanum, modifying conventional dialysis regimens to improve phosphate clearance is an alternative approach that remains relatively unstudied. A secondary analysis of a previous randomized cross-over study from our group found that the use of two dialysers in parallel resulted in a reduction in pre-dialysis serum phosphate levels. As this study was small, and the mechanisms resulting in the reduction in phosphate levels were unclear, further study is warranted. The investigators will conduct a randomized cross-over study comparing the impact of dialyzing using two dialysers in parallel with a single dialyser in hyperphosphatemic hemodialysis patients.
There will be a total of 34 participants from Alberta,Canada participating in this study. The length of study participation is 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dialyzer | Active comparator | Procedure: Single dialyzerSingle dialyzer |
| Double dialyzer | Experimental | Procedure: Two dialyzersTwo dialyzers in parallel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Patients must be on a stable regimen of hemodialysis for ≥ 3 months ('stable' defined as not expected to require a change to the duration or frequency of treatments)
- Serum phosphate > 1.6 mmol/l on last two consecutive lab tests at least 3 weeks apart (KDOQI guidelines recommend maintaining predialysis phosphate < 1.8mmol/l - as such, phosphate lowering in this subgroup of patients is particularly relevant)
- Patients must be on stable doses of a phosphate binder with no changes in dose 1 month prior to study enrolment.
- Blood flow rate ≥ 350 ml/min through a well-functioning access (This will exclude patients receiving inadequate dialysis due to a temporary venous dialysis catheter and will ensure sufficient blood flow to permit dialysis using two dialysers in parallel.)
Key exclusion criteria (7 listed)
- Patients who have a scheduled renal transplant, change in dialysis modality, surgery or hospitalization or plan on moving away from the study site in the next three months.
- Patients with a projected life expectancy of less than 3 months.
- Patients with a contraindication to intra-dialytic anticoagulation. (Some patients require a small increase in the amount of anticoagulation required to prevent dialyser clotting when using two dialysers in parallel).
- Patients who have missed >8 dialysis treatments in the past 3 months.
- Patients with a dialysis regimen of >3 runs per week.
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 |
|---|---|---|
| Single dialyzerHemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment. | Procedure or surgery | Single dialyzer |
| Two dialyzersHemodialysis treatment using a two Baxter dialyzers in parallel. | Procedure or surgery | Double dialyzer |
Primary outcome
Dialysate clearance of phosphate
Time frame: 3 weeks
Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.
2 secondary outcomes
Serum phosphate
Time frame: 3 weeks
Dialysate removal of phosphate
Time frame: 3 weeks
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 2016.
- Results publication: PubMed 27190374Thompson S, Manns B, Lloyd A, Hemmelgarn B, MacRae J, Klarenbach S, Unsworth L, Courtney M, Tonelli M. Impact of using two dialyzers in parallel on phosphate clearance in hemodialysis patients: a randomized trial. Nephrol Dial Transplant. 2017 May 1;32(5):855-861. doi: 10.1093/ndt/gfw085.
- Individual participant dataSharing planned: No
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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.
Marcello Tonelli, MD principal investigator
University of Alberta
Braden Manns, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dialyzer and Two dialyzers in people with End Stage Renal Disease, run by University of Alberta at 2 sites 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 5 inclusion and 7 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 2016. 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 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?
Dialysate clearance of phosphate (time frame: 3 weeks). 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 NCT01539252, which also lists 1 linked publication.
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 2016.