Chronic Kidney FailureRHODESNCT00781690
Reduction of Heparin Dose in Dialysis With Evodial System
A study testing Evodial hemodialysers and Evodia blood lines in people with Chronic Kidney Failure, run by Vantive Health LLC at 7 sites in 4 countries.
Trial summary
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Evodial hemodialysers and Evodia blood lines
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Sep 2008to Feb 2010
- 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 suffering from chronic renal failure,
- Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter,
- Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min,
- Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used,
- Patients with a well-functioning vascular access as judged by the investigator,
- Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device,
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- Patients older than 18 years,
- Patients with negative serologies (AIDS, Hepatitis)
- Patients having signed consent to participate in the study.
Who cannot join
- Patient with HIT or known heparin allergy,
- Patient treated in HD in single needle mode,
- Patients with catheter,
- Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results,
- Patients participating in other studies that could interfere with the objective of this study,
- Patients with active malignant disease,
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- Patients receiving heparin outside dialysis treatment,
- Patients under guardianship,
- Pregnant women, nursing mothers and women planning a pregnancy during the course of this study,
- Patients with serious history of coagulopathy,
- Patients receiving Anti-Vitamin K medication,
- Patients receiving an association of anti platelets agents,
- Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction).
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
France4 sites
Calydial dialysis unit
Irigny, 69540
Clinique St Exupéry
Toulouse, 31400
Hopital Brabois
Vandœuvre-lès-Nancy, 54511
ALTIR Dialysis center
Vandœuvre-lès-Nancy
About this study
Official title: Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
Read the detailed description
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.
The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.
The study will be divided into three steps
- Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines (baseline),
- Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines
- Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer and SMA bloodlines.
Each patient included into the study will perform the three steps. As the risk of extracorporeal circuit clotting will be rather important, no control group (usual hemodialyzer with heparin decrease dose) will be performed.
- Conditions
- Chronic Kidney Failure
- Being tested
- Evodial hemodialysers and Evodia blood lines
- Keywords
- Chronic kidney failure, Heparin, Hemodialysis, Biocompatibility
- 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.
Evodial hemodialysers and Evodia blood linesDevice
Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with Evodial with reduction of heparin across study period Receives: Device: Evodial hemodialysers and Evodia blood lines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
Measured: End of dialysis treatment
Secondary outcomes (5)
Follow-up of aPTT for patients treated with UFH,
Measured: Kinetic on single dialysis treatment
Evaluation of TAT (Thrombin-Antithrombin) complex,
Measured: Kinetic on single dialysis treatment
Follow-up of ionic clearance (Diascan) measurements during HD sessions,
Measured: Kinetic of single dialysis treatment
Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,
Measured: End of dialysis treatment
Follow-up of AE/SAE.
Measured: All treatments during study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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 Chronic Kidney FailureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Michèle Kessler, Pf, Study chair, Hopital Brabois, Vandoeuvre les Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781690
- Sponsor's protocol ID
- 1456
- Other IDs
- ISRCTN 93952087
- Acronym
- RHODES
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2008
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. doi: 10.1093/ndt/gfg272.
PubMed 13679486Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21.
PubMed 18156457Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.
PubMed 22925178
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
- ClinicalTrials.gov ID
- NCT00781690
- Acronym / sponsor ID
- RHODES / 1456
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic kidney failure, Heparin, Hemodialysis, Biocompatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Study start
- Sep 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Oct 2008 (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 current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
Detailed description
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.
The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.
The study will be divided into three steps
- Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines (baseline),
- Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines
- Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer and SMA bloodlines.
Each patient included into the study will perform the three steps. As the risk of extracorporeal circuit clotting will be rather important, no control group (usual hemodialyzer with heparin decrease dose) will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Evodial hemodialysers and Evodia blood linesTreatment with Evodial with reduction of heparin across study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients suffering from chronic renal failure,
- Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter,
- Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min,
- Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used,
- Patients with a well-functioning vascular access as judged by the investigator,
Key exclusion criteria (13 listed)
- Patient with HIT or known heparin allergy,
- Patient treated in HD in single needle mode,
- Patients with catheter,
- Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results,
- Patients participating in other studies that could interfere with the objective of this study,
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 |
|---|---|---|
| Evodial hemodialysers and Evodia blood linesMaximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose | Device | 1 |
Primary outcome
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
Time frame: End of dialysis treatment
5 secondary outcomes
Follow-up of aPTT for patients treated with UFH,
Time frame: Kinetic on single dialysis treatment
Evaluation of TAT (Thrombin-Antithrombin) complex,
Time frame: Kinetic on single dialysis treatment
Follow-up of ionic clearance (Diascan) measurements during HD sessions,
Time frame: Kinetic of single dialysis treatment
Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,
Time frame: End of dialysis treatment
Follow-up of AE/SAE.
Time frame: All treatments during study period
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 13 Mar 2025.
- Background: PubMed 13679486Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. doi: 10.1093/ndt/gfg272.
- Background: PubMed 18156457Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21.
- Derived from this study: PubMed 22925178Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.
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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.
Michèle Kessler, Pf study chair
Hopital Brabois, Vandoeuvre les Nancy
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evodial hemodialysers and Evodia blood lines in people with Chronic Kidney Failure, run by Vantive Health LLC at 7 sites in 4 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 9 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Italy, Sweden. 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?
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. (time frame: End of dialysis treatment). 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 NCT00781690, 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 13 Mar 2025.