Renal InsufficiencyRESTITNCT05117450
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
A study testing Decrease per-dialytic heparin therapy in people with Renal Insufficiency, run by CHU de Reims at 1 site in France.
Trial summary
Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Decrease per-dialytic heparin therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2021to 17 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with Age > 18 years
- Chronic hemodialysis for at least 3 months
- Hemodialysis three times a week
- On per dialytic heparin therapy (UFH or LMWH)
- Affiliated to the French Social Security
- Having given their consent for this study
Who cannot join
- Patients undergoing Hemodiafiltration (HDF)
- Pregnant or lactating woman
- Patient participating in another interventional study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (under guardianship or curators)
- Persons under a legal protection measure
Show all 18Show fewer
- Patients with a history of HIT
- Patients with acquired or congenital coagulation disorders
- Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)
- Patient on an ACE inhibitor (ACE inhibitor)
- Patient requiring transfusion during the study period
- Patient not hemoglobin-stabilized (mean Hb < 10g/dL or >12 g/dL in the previous month)
- Patient septic or with significant inflammation (defined as C-reactive protein > 25mg/L) at the time of inclusion
- Patient requiring per-dialytic parenteral nutrition
- Patient requiring hospitalization or scheduled surgery during the study period
- Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (< 300 mL/min determined during the screening phase = blood flow prescribed by the nephrologist)
- Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session
- Net ultrafiltration on the day of the screening session > 4000 mL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.
To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.
Read more
In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.
The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session
Read the detailed description
The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients.
Participation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane.
- Conditions
- Renal Insufficiency
- Being tested
- Decrease per-dialytic heparin therapy
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decrease per-dialytic heparin therapyDevice
Decrease per-dialytic heparin therapy with the HYDROLINK membrane (dialyzer NV-21U, surface 2.1m², Toray industry, Tokyo, Japan) and with the HeprAN membrane (dialyzer Evodial 2.2, surface 2.15 m2, Hospal SAS, Meyzieu, France)
| Study group | Role | What they receive |
|---|---|---|
| HeprAN first | Active comparator | Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK Receives: Device: Decrease per-dialytic heparin therapy |
| HYDROLINK first | Active comparator | Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane Receives: Device: Decrease per-dialytic heparin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hemodialysis session success without heparin
The success of the hemodialysis session is defined by a dialysis time> 95% of the prescribed time
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start17 Nov 2021
- Primary completion17 Nov 2026 (estimated)
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117450
- Sponsor's protocol ID
- PO20179*
- Acronym
- RESTIT
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05117450
- Acronym / sponsor ID
- RESTIT / PO20179*
- Conditions
- Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 11 Nov 2021 (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.
Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.
To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.
In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.
The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session
Detailed description
The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients.
Participation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeprAN first | Active comparator | Device: Decrease per-dialytic heparin therapyEach included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK |
| HYDROLINK first | Active comparator | Device: Decrease per-dialytic heparin therapyEach included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane |
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 with Age > 18 years
- Chronic hemodialysis for at least 3 months
- Hemodialysis three times a week
- On per dialytic heparin therapy (UFH or LMWH)
- Affiliated to the French Social Security
Key exclusion criteria (18 listed)
- Patients undergoing Hemodiafiltration (HDF)
- Pregnant or lactating woman
- Patient participating in another interventional study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (under guardianship or curators)
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 |
|---|---|---|
| Decrease per-dialytic heparin therapyDecrease per-dialytic heparin therapy with the HYDROLINK membrane (dialyzer NV-21U, surface 2.1m², Toray industry, Tokyo, Japan) and with the HeprAN membrane (dialyzer Evodial 2.2, surface 2.15 m2, Hospal SAS, Meyzieu, France) | Device | HYDROLINK first, HeprAN first |
Primary outcome
number of hemodialysis session success without heparin
Time frame: 4 weeks
The success of the hemodialysis session is defined by a dialysis time> 95% of the prescribed time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decrease per-dialytic heparin therapy in people with Renal Insufficiency, run by CHU de Reims at 1 site in France.
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 18 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine BRACONNIER (03 26 78 41 40 ext. 0033, abraconnier@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hemodialysis session success without heparin (time frame: 4 weeks). 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 21 Nov 2025.