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Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients (RHEO-PAD)

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ClinicalTrials.gov Identifier: NCT03975946
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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).


Condition or disease Intervention/treatment Phase
Hemodialysis Procedure: Rheopheresis procedure Biological: Blood Sample Procedure: Shamapheresis procedure Not Applicable

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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
Estimated Study Start Date : December 12, 2019
Estimated Primary Completion Date : June 12, 2024
Estimated Study Completion Date : June 12, 2024

Resource links provided by the National Library of Medicine


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

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.




Primary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975946


Contacts
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Contact: Thomas ROBERT, PH 491384095 ext +33 thomas.robert@ap-hm.fr
Contact: Jean-Olivier ARNAUD, Director 491382747 ext +33 drci@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Not yet 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         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03975946     History of Changes
Other Study ID Numbers: 2018-68
2019-A01513-54 ( Other Identifier: ID RCB )
RCAPHM18_0384 ( Other Identifier: AP-HM )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases