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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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