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Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients (RHEO-PAD)
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemodialysis | Procedure: Rheopheresis procedure Biological: Blood Sample Procedure: Shamapheresis procedure | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 260 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Masking Description: | The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial |
| Actual Study Start Date : | June 12, 2020 |
| Estimated Primary Completion Date : | June 12, 2024 |
| Estimated Study Completion Date : | June 12, 2024 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: the rheopheresis group |
Procedure: Rheopheresis procedure
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.
Biological: Blood Sample Biological analysis
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| Placebo Comparator: the shamapheresis group |
Biological: Blood Sample
Biological analysis
Procedure: Shamapheresis procedure 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.
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- 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)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 - Medical insurance - Signed informed consent
Exclusion Criteria:
- Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area
- Pregnancy or breastfeeding
- Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) - Life expectancy greater than 1 year - Severe cognitive or psychiatric disorders
| Contact: Thomas ROBERT, PH | 491384095 ext +33 | thomas.robert@ap-hm.fr | |
| Contact: Jean-Olivier ARNAUD, Director | 491382747 ext +33 | drci@ap-hm.fr |
| France | |
| Assistance Publique Hôpitaux de Marseille | Recruiting |
| Marseille, France, 13354 | |
| Contact: Thomas ROBERT, PH 491384095 ext +33 thomas.robert@ap-hm.fr | |
| Contact: Jean-Olivier ARNAUD, Director 491382747 ext +33 drci@ap-hm.fr | |
| Principal Investigator: Thomas ROBERT, PH | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||||||
| First Posted Date ICMJE | June 5, 2019 | ||||||||
| Last Update Posted Date | June 19, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 12, 2020 | ||||||||
| Estimated Primary Completion Date | June 12, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients | ||||||||
| Official Title ICMJE | Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial | ||||||||
| Brief 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. 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). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Masking Description: The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation Primary Purpose: Treatment
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| Condition ICMJE | Hemodialysis | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
260 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 12, 2024 | ||||||||
| Estimated Primary Completion Date | June 12, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03975946 | ||||||||
| Other Study ID Numbers ICMJE | 2018-68 2019-A01513-54 ( Other Identifier: ID RCB ) RCAPHM18_0384 ( Other Identifier: AP-HM ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Assistance Publique Hopitaux De Marseille | ||||||||
| Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Assistance Publique Hopitaux De Marseille | ||||||||
| Verification Date | June 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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