Kidney DiseasesEvoCit-HDNCT03887468
Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate
A study testing EvoCit and EvoHep in people with Kidney Diseases and Hemodialysis Complication, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial summary
After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure"). After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Hemodialysis Complication, End Stage Renal Disease
- What is being tested?
- EvoCit and EvoHep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 May 2018to 4 Dec 2019
- 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 or hemodiafiltration since at least three months.
- Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.
- ≥ 18 years of age.
- Patients able and agree to provide signed informed consent.
Who cannot join
- Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port1.
- Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.
- Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.
- Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
- 1 or more results of spKt/Vurea < 1,35 during the last three months prior to study inclusion.
- Need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion.
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- Vascular access dysfunction defined as
- use of urokinase the 2 months before study inclusion, including to restore catheter permeability.
- non-tunneled hemodialysis catheter use.
- known AV access outflow tract stenosis.
- planned vascular access intervention.
- planned vascular access conversion.
- Known allergy against heparin grafted AN69STmembranes.
- Use of ACE-inhibitor
- Use of vitamin K antagonist
- Use of novel oral anticoagulant therapy.
- Any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator.
- Planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy).
- Symptomatic hypocalcemia.
- Hb < 8g/dl at screening.
- Hct > 45% at screening.
- Perdialytic total parenteral nutrition therapy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)
After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").
After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.
- Being tested
- EvoCit, EvoHep
- Keywords
- dialysis adequacy, clotting
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvoCitDevice
hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
EvoHepDevice
hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin
| Study group | Role | What they receive |
|---|---|---|
| "EvoCit" | Active comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: "EvoCit procedure" using a heparin-grafted AN69ST dialyzer in combination with a citric acid enriched dialysate without any systemic anticoagulation. Receives: Device: EvoCit |
| "EvoHep" | Active comparator | Control: "EvoHep procedure" using a heparin-grafted AN69ST dialyzer in combination with a conventional bicarbonate-based dialysate and standardized systemic anticoagulation using unfractionated heparin. Receives: Device: EvoHep |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in dialysis adequacy
spKt/Vurea
Measured: every midweek dialysis session through study duration, ie 2x4 weeks
Secondary outcomes (5)
proportion of thrombotic dysfunction
premature termination of the dialysis session
Measured: every HD session through study duration, ie 2x4 weeks
change in dialysis adequacy expressed by middle molecule (MM) clearance
MM clearances
Measured: every 1st and 4th week HD session through study duration, ie 2x4 weeks
occurence of complete circuit thrombosis
rapidly occurring thrombosis of the extracorporeal circuit, which does not allow complete retransfusion of the blood circuit even if prescribed treatment duration is reached
Measured: every HD session through study duration, ie 2x4 weeks
change in membrane coagulation
total cell volume measurement of the dialyzer after hemodialysis
Measured: every midweek HD session through study duration, ie 2x4 weeks
occurence of biological evaluation of coagulation activation
TAT, PF1+2,
Measured: every 1st and 4th week HD session through study duration, ie 2x4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start15 May 2018
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887468
- Sponsor's protocol ID
- UZB-NEF-2017-EvoCit-HD
- Acronym
- EvoCit-HD
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 38189593Francois K, De Clerck D, Tonnelier A, Cambier ML, Orlando C, Jochmans K, Cools W, Wissing KM. Dialyzer Performance During Hemodialysis Without Systemic Anticoagulation Using a Heparin-Grafted Dialyzer Combined With a Citrate-Enriched Dialysate: Results of the Randomized Crossover Noninferiority EvoCit Study. Am J Kidney Dis. 2022 Jan;79(1):79-87.e1. doi: 10.1053/j.ajkd.2021.04.004. Epub 2021 Apr 30.
PubMed 33940113
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)
- ClinicalTrials.gov ID
- NCT03887468
- Acronym / sponsor ID
- EvoCit-HD / UZB-NEF-2017-EvoCit-HD
- Keywords
- dialysis adequacy, clotting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 25 Mar 2019 (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.
After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").
After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "EvoCit" | Active comparator | Device: EvoCitStandardized hemodialysis treatments 3x4hours/week. Intervention: "EvoCit procedure" using a heparin-grafted AN69ST dialyzer in combination with a citric acid enriched dialysate without any systemic anticoagulation. |
| "EvoHep" | Active comparator | Device: EvoHepControl: "EvoHep procedure" using a heparin-grafted AN69ST dialyzer in combination with a conventional bicarbonate-based dialysate and standardized systemic anticoagulation using unfractionated heparin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients treated with hemodialysis or hemodiafiltration since at least three months.
- Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.
- ≥ 18 years of age.
- Patients able and agree to provide signed informed consent.
Key exclusion criteria (22 listed)
- Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port1.
- Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.
- Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.
- Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
- 1 or more results of spKt/Vurea < 1,35 during the last three months prior to study inclusion.
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 |
|---|---|---|
| EvoCithemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate | Device | "EvoCit" |
| EvoHephemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin | Device | "EvoHep" |
Primary outcome
change in dialysis adequacy
Time frame: every midweek dialysis session through study duration, ie 2x4 weeks
spKt/Vurea
5 secondary outcomes
proportion of thrombotic dysfunction
Time frame: every HD session through study duration, ie 2x4 weeks
change in dialysis adequacy expressed by middle molecule (MM) clearance
Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
occurence of complete circuit thrombosis
Time frame: every HD session through study duration, ie 2x4 weeks
change in membrane coagulation
Time frame: every midweek HD session through study duration, ie 2x4 weeks
occurence of biological evaluation of coagulation activation
Time frame: every 1st and 4th week HD session through study duration, ie 2x4 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 18 Jan 2020.
- 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.
- Derived from this study: PubMed 33940113Francois K, De Clerck D, Tonnelier A, Cambier ML, Orlando C, Jochmans K, Cools W, Wissing KM. Dialyzer Performance During Hemodialysis Without Systemic Anticoagulation Using a Heparin-Grafted Dialyzer Combined With a Citrate-Enriched Dialysate: Results of the Randomized Crossover Noninferiority EvoCit Study. Am J Kidney Dis. 2022 Jan;79(1):79-87.e1. doi: 10.1053/j.ajkd.2021.04.004. Epub 2021 Apr 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EvoCit and EvoHep in people with Kidney Diseases and Hemodialysis Complication, run by Universitair Ziekenhuis Brussel at 2 sites 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 4 inclusion and 22 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 18 Jan 2020. 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 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 dialysis adequacy (time frame: every midweek dialysis session through study duration, ie 2x4 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 NCT03887468, which also lists 2 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 18 Jan 2020.