End Stage Renal Diseasec-phactNCT03090984
Evaluation of Contact Phase Activation During Hemodialysis
A study testing PMMA (BKU), PS (Phylter) and AN69ST (Evodial) in people with End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized. 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?
- PMMA (BKU), PS (Phylter) and AN69ST (Evodial)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 8 May 2017to 24 Jul 2017
- 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
- Patients treated with hemodialysis since at least three months.
- Hemodialysis treatment schedule of 3 x 4 hours weekly.
- Arteriovenous fistula (AVF) use for vascular access.
- Treatment with oral acetylsalicylic acid 80 or 100mg q every day.
- ≥ 18 years of age.
- Patients able and agree to provide signed informed consent.
Who cannot join
- Use of vitamin K antagonists or novel oral anticoagulant therapy.
- Use of chronic heparin treatment, UFH or LMWH.
- Use of clopidogrel.
- Use of ACE-inhibitors.
- Known allergy against one of the dialysis membranes used during this study (PMMA: BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).
- Known heparin-induced trombopenia type 2.
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- Active infection and/or ongoing systemic antimicrobial treatment.
- Presence of central venous catheter, tunnelled or non-tunnelled and/or AV graft.
- Hospitalized patients.
- Planned surgery during study period.
- Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
- Vascular access dysfunction defined as (a) known AV access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion.
- Planned conversion of dialysis modality during study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.
During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).
- Conditions
- End Stage Renal Disease
- Being tested
- PMMA (BKU), PS (Phylter), AN69ST (Evodial)
- Keywords
- Hemodialysis, Coagulation activation
- 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.
PMMA (BKU)Device
At serial time points before, during and after each study hemodialysis session using a BKU dialyzer, blood samples will be drawn for coagulation activation analyses.
PS (Phylter)Device
At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation
AN69ST (Evodial)Device
At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation
| Study group | Role | What they receive |
|---|---|---|
| PMMA (BKU) | Active comparator | Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF). Receives: Device: PMMA (BKU) |
| PS (Phylter) | Active comparator | Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. Receives: Device: PS (Phylter) |
| AN69ST (Evodial) | Active comparator | Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. Receives: Device: AN69ST (Evodial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
ELISA testing for plasma kallikrein (pg/mL).
Measured: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
Chromogenic test for plasma fXIa (mIU/mL).
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
ELISA testing for plasma fXIIa (pg/mL).
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary outcomes (4)
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.
ELISA testing for plasma TAT (µg/L).
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.
ELISA testing for plasma PF1+2 (pmol/L).
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.
Immunoassay for plasma d-dimers (ng/mL)
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor
ELISA testing for plasme Tissue Factor (pg/mL)
Measured: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start8 May 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
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 Universitair Ziekenhuis BrusselThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karlien François, Universitair Ziekenhuis Brussel
- Investigators
- Karlien François, MD, Principal investigator, UZ Brussel, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090984
- Sponsor's protocol ID
- UZB-NEF-2016-contactphase
- Acronym
- c-phact
- Status last verified
- Aug 2017
- First submitted
- 10 Feb 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PubMed 38189593
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03090984
- Acronym / sponsor ID
- c-phact / UZB-NEF-2016-contactphase
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Coagulation activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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.
Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.
During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMMA (BKU) | Active comparator | Device: PMMA (BKU)Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF). |
| PS (Phylter) | Active comparator | Device: PS (Phylter)Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. |
| AN69ST (Evodial) | Active comparator | Device: AN69ST (Evodial)Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients treated with hemodialysis since at least three months.
- Hemodialysis treatment schedule of 3 x 4 hours weekly.
- Arteriovenous fistula (AVF) use for vascular access.
- Treatment with oral acetylsalicylic acid 80 or 100mg q every day.
- ≥ 18 years of age.
Key exclusion criteria (13 listed)
- Use of vitamin K antagonists or novel oral anticoagulant therapy.
- Use of chronic heparin treatment, UFH or LMWH.
- Use of clopidogrel.
- Use of ACE-inhibitors.
- Known allergy against one of the dialysis membranes used during this study (PMMA: BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).
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 |
|---|---|---|
| PMMA (BKU)At serial time points before, during and after each study hemodialysis session using a BKU dialyzer, blood samples will be drawn for coagulation activation analyses. | Device | PMMA (BKU) |
| PS (Phylter)At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation | Device | PS (Phylter) |
| AN69ST (Evodial)At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation | Device | AN69ST (Evodial) |
Primary outcome
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
Time frame: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
ELISA testing for plasma kallikrein (pg/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Chromogenic test for plasma fXIa (mIU/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
ELISA testing for plasma fXIIa (pg/mL).
4 secondary outcomes
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor
Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
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 15 Aug 2017.
- Derived from this study: PubMed 38189593Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
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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.
Karlien François, MD principal investigator
UZ Brussel, Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMMA (BKU), PS (Phylter) and AN69ST (Evodial) in people with End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 6 inclusion and 13 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 15 Aug 2017. 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 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?
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein. (time frame: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.). 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?
On the ClinicalTrials.gov record for NCT03090984, 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 15 Aug 2017.