Status:

RECRUITING

Rheopheresis as Adjuvant Treatment of Calciphylaxis

Lead Sponsor:

University Hospital, Lille

Collaborating Sponsors:

Direction Générale de l'Offre de Soins

Conditions:

Metabolic Disorder

End Stage Renal Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis...

Detailed Description

Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and sub...

Eligibility Criteria

Inclusion Criteria:

  • Calciphylaxis with at least one ulcerated or necrotizing lesion
  • End stage renal disease requiring hemodialysis
  • Weight superior to 30kg
  • Subject affiliated to or beneficiary of a social security system
  • Subject having signed written informed consent

A patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included.

Exclusion Criteria:

  • KARNOFSKY Performance Status Scale inferior to 30%
  • Life expectancy (independently of calciphylaxis) estimated < 6 months according to a referring physician expert in hemodialysis
  • Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)
  • Common variable immunodeficiency
  • Albumin allergy
  • Contra-indication to stop anti-vitamin K treatment
  • Severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study
  • 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.

Key Trial Info

Start Date :

March 7 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT04654000

Start Date

March 7 2023

End Date

May 1 2027

Last Update

February 12 2026

Active Locations (29)

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Page 1 of 8 (29 locations)

1

CHU d'Angers

Angers, France, 49933

2

CHU d'Arras

Arras, France, 62022

3

CHU d'Auxerre

Auxerre, France, 89011

4

CHU de Besançon, Hôpital Jean Minjoz

Besançon, France, 25000

Rheopheresis as Adjuvant Treatment of Calciphylaxis | DecenTrialz