NCT03975946: RHEO-PAD

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

Status unknown NA Last updated 27 July 2023

What this trial tests

NA trial testing Rheopheresis procedure in Hemodialysis in 260 participants. Status unknown.

Timeline

14 January 2021

Primary endpoint
12 June 2024

12 June 2024

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	260
Start date	14 January 2021
Primary completion	12 June 2024
Estimated completion	12 June 2024
Sites	1 location across France

Drugs / interventions tested

• Rheopheresis procedure
• Blood Sample — full drug profile →
• Shamapheresis procedure

Conditions studied

• Hemodialysis — all drugs for Hemodialysis →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, any sex, with Hemodialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical management of peripheral arterial disease in chronic kidney disease-a comprehensive review from the European Renal Association CKD-MBD Working Group.
   Huish S, Nawaz S, Bellasi A, Diaz-Tocados JM, et al · · 2025 · cited 4× · PMID 40599821 · DOI 10.1093/ckj/sfaf089
2. Role of Lipids and Lipid Management Therapy Among Patients With Peripheral Artery Disease: A Reappraisal of the Current Evidence and Future Directions.
   Walker M, Riggs KA, Rohatgi A, Beckman J, et al · · 2025 · PMID 40970523 · DOI 10.1161/jaha.124.039734