← Back to Clinical Trials
RecruitingNCT04654000

Rheopheresis as Adjuvant Treatment of Calciphylaxis

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

ConditionMetabolic Disorder
SponsorUniversity Hospital, Lille
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment138
SexALL
Min Age18 Years
Max AgeN/A
Start Date2023-03-07
Completion2027-04
Interventions
Rheopheresis procedureSham-apheresis

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 in the hemodialysis population.

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 speci

Related Trials