Rheopheresis as Adjuvant Treatment of Calciphylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rheopheresis procedure
Procedure/Surgeryrheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
Sham-apheresis
Procedure/SurgerySham-apheresis 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.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Rheopheresis groupExperimental treatment 1 intervention
Group B: Sham-apheresis groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
Complete wound healing is defined as the absence of livedoid peri-lesional inflammation with presence of granulation tissue (stage 3 healing process) and/or epithelization (stage 4) over the entire ulcer surface of calciphylactic lesions. The healing of the lesions will be illustrated with a photographic support. And the pictures will be examined a second time in a centralized and blind way by two referring dermatologists. In case of multiple calciphylaxis skin lesions, monitoring and evaluation will be done on the largest lesion at the time of patient's inclusion.
Time frame
at 12 weeks of treatementSecondary outcomes
1
Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.
The partial healing is defined by a partial reepithelialization (validated if 3 of following 4 criteria are present: 1-absence of necrosis; 2- granulation; 3 less inflammatory bordering 4- 20% decrease of the lesion size). The evolution of the size of the lesions and the partial healing of the wound will be illustrated by a photographic support.
Time frame
At 4 weeks and 12 weeks of rheopheresis treatment.2
Occurrence of new ulcerated calciphylaxis lesions
Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment.
Time frame
At 4 weeks and 12 weeks of rheopheresis treatment.3
Evolution of the self-reporting pain using Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) describes the pain intensity at 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Time frame
from baseline (V0) to 12 weeks of rheopheresis (V2)4
Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification
The level of consumed antalgic is defined according to the World Health Organization (WHO) classification * Level I analgesics = peripheral analgesics or not morphine have the lowest analgesic power * Level II analgesics = weak morphine. * Level III analgesics = strong morphine agonists and antagonists.
Time frame
from baseline (V0) to 12 weeks of rheopheresis (V2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov