HemodialysisRHEO-PADNCT03975946
Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients
A study testing Rheopheresis procedure and Blood Sample in people with Hemodialysis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Rheopheresis procedure and Blood Sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 12 Jun 2024
- 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 or more
- End stage renal disease (ESRD) treated by hemodialysis or hemodiafiltration
- PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion: arterial pressure assessment at the ankle <70 millimeter of mercury (mmHg), or toe pressure 30 mmHg, or transcutaneous oximetry measurements < 40 mmHg
- Interventional or surgical revascularization either not technically possible or no necessary. Or if revascularization has already been performed and the diagnosis of chronic critical ischemia is maintained.
- Female of childbearing potential, will have to use highly effective methods of contraception from study start to the end.
- Medical insurance
- Signed informed consent
Who cannot join
- Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area
- Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
- Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)
- Life expectancy greater than 1 year
- Severe cognitive or psychiatric disorders
- History of allergic reaction to dialysis membrane
- Patients unable to give an informed consent or unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Thomas ROBERT, PH, 491384095 ext. +33, thomas.robert@ap-hm.fr
Jean-Olivier ARNAUD, Director, 491382747 ext. +33, drci@ap-hm.fr
About this study
Official title: Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial
Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Conservative treatments have limited efficacy in patients with end-stage renal disease (ESRD). There is no alternative treatment for patients with PAD-LTI in hemodialysis.
Rheopheresis is an apheresis technique specifically designed for the treatment of microcirculatory disorders in which anomalies of rheology are at the center of physiopathology. This double cascade plasma filtration technique reduces plasma viscosity and eliminates inflammation mediators which play an essential role in PAD. This technique has already shown its effectiveness in a randomized trial in dry Age-related macular degeneration (AMD), another pathology of microcirculation. The effectiveness of rheopheresis in PAD-LTI has only been reported in a small number of cases.
This Hypothesis is that the treatment of microcirculation by rheopheresis would improve wound healing of the ischemic lesion and/or reduce major amputation and thus the prognosis of the affected limb of the patient with PAD-LTI in hemodialysis. This objective is to demonstrate the efficacy of rheopheresis, (twelve sessions), to avoid major amputation and reaches complete wound healing of ischemic lesion in the dialysis patient population with PAD-LTI. This study is prospective, Controlled, Parallel, Randomized, Single blind and Multicentric in France (12 French centers).
- Conditions
- Hemodialysis
- Being tested
- Rheopheresis procedure, Blood Sample, Shamapheresis procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis procedureProcedure or surgery
Rheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor.
Blood SampleBiological
Biological analysis
Shamapheresis procedureProcedure or surgery
Shamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor.
| Study group | Role | What they receive |
|---|---|---|
| the rheopheresis group | Active comparator | Not described Receives: Procedure: Rheopheresis procedure; Biological: Blood Sample |
| the shamapheresis group | Placebo comparator | Not described Receives: Biological: Blood Sample; Procedure: Shamapheresis procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of complete wound healing of the ischemic lesions
Complete wound healing will be assessed clinically by complete epithelialization of the ischemic lesion
Measured: 8 months
Percentage of absence of major amputation.
Major amputation will be defined as above-the-knee amputation (AKAs) and below-the-knee amputation above the ankle (BKAs)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start14 Jan 2021
- Primary completion12 Jun 2024 (estimated)
- Study completion12 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975946
- Sponsor's protocol ID
- 2018-68
- Other IDs
- 2019-A01513-54, RCAPHM18_0384
- Acronym
- RHEO-PAD
- Status last verified
- Jul 2023
- First submitted
- 31 May 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial
- ClinicalTrials.gov ID
- NCT03975946
- Acronym / sponsor ID
- RHEO-PAD / 2018-68
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 12 Jun 2024 (estimated)
- Study completion
- 12 Jun 2024 (estimated)
- First posted
- 5 Jun 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.
Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Conservative treatments have limited efficacy in patients with end-stage renal disease (ESRD). There is no alternative treatment for patients with PAD-LTI in hemodialysis.
Rheopheresis is an apheresis technique specifically designed for the treatment of microcirculatory disorders in which anomalies of rheology are at the center of physiopathology. This double cascade plasma filtration technique reduces plasma viscosity and eliminates inflammation mediators which play an essential role in PAD. This technique has already shown its effectiveness in a randomized trial in dry Age-related macular degeneration (AMD), another pathology of microcirculation. The effectiveness of rheopheresis in PAD-LTI has only been reported in a small number of cases.
This Hypothesis is that the treatment of microcirculation by rheopheresis would improve wound healing of the ischemic lesion and/or reduce major amputation and thus the prognosis of the affected limb of the patient with PAD-LTI in hemodialysis. This objective is to demonstrate the efficacy of rheopheresis, (twelve sessions), to avoid major amputation and reaches complete wound healing of ischemic lesion in the dialysis patient population with PAD-LTI. This study is prospective, Controlled, Parallel, Randomized, Single blind and Multicentric in France (12 French centers).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the rheopheresis group | Active comparator | Procedure: Rheopheresis procedure, Biological: Blood Sample |
| the shamapheresis group | Placebo comparator | Biological: Blood Sample, Procedure: Shamapheresis procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or more
- End stage renal disease (ESRD) treated by hemodialysis or hemodiafiltration
- PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion: arterial pressure assessment at the ankle <70 millimeter of mercury (mmHg), or toe pressure 30 mmHg, or transcutaneous oximetry measurements < 40 mmHg
- Interventional or surgical revascularization either not technically possible or no necessary. Or if revascularization has already been performed and the diagnosis of chronic critical ischemia is maintained.
- Female of childbearing potential, will have to use highly effective methods of contraception from study start to the end.
Key exclusion criteria (7 listed)
- Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area
- Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
- Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)
- Life expectancy greater than 1 year
- Severe cognitive or psychiatric disorders
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 |
|---|---|---|
| Rheopheresis procedureRheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor. | Procedure or surgery | the rheopheresis group |
| Blood SampleBiological analysis | Biological | the rheopheresis group, the shamapheresis group |
| Shamapheresis procedureShamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor. | Procedure or surgery | the shamapheresis group |
Primary outcome
Percentage of complete wound healing of the ischemic lesions
Time frame: 8 months
Complete wound healing will be assessed clinically by complete epithelialization of the ischemic lesion
Percentage of absence of major amputation.
Time frame: 8 months
Major amputation will be defined as above-the-knee amputation (AKAs) and below-the-knee amputation above the ankle (BKAs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheopheresis procedure and Blood Sample in people with Hemodialysis, run by Assistance Publique Hopitaux De Marseille 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 7 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas ROBERT, PH (491384095 ext. +33, thomas.robert@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of complete wound healing of the ischemic lesions (time frame: 8 months). The study lists 2 primary outcomes in all. 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 27 Jul 2023.