Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients

NCT ID: NCT03975946

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2024-06-12

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).

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the rheopheresis group

Group Type: ACTIVE_COMPARATOR

Rheopheresis procedure

Intervention Type: 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.

Blood Sample

Intervention Type: BIOLOGICAL

Biological analysis

the shamapheresis group

Group Type: PLACEBO_COMPARATOR

Blood Sample

Intervention Type: BIOLOGICAL

Biological analysis

Shamapheresis procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Blood Sample

Biological analysis

Intervention Type: BIOLOGICAL

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.

Intervention Type: PROCEDURE

Eligibility 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. 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas ROBERT, PH

Role: CONTACT

thomas.robert@ap-hm.fr

491384095 ext. +33

Jean-Olivier ARNAUD, Director

Role: CONTACT

drci@ap-hm.fr

491382747 ext. +33

Facility Contacts

Thomas ROBERT, PH

Role: primary

thomas.robert@ap-hm.fr

491384095 ext. +33

Jean-Olivier ARNAUD, Director

Role: backup

drci@ap-hm.fr

491382747 ext. +33

Other Identifiers

2019-A01513-54

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM18_0384

Identifier Type: OTHER

Identifier Source: secondary_id

2018-68

Identifier Type: -

Identifier Source: org_study_id