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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04654000
Other study ID # 2020_05
Secondary ID 2020-A02896-33
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date May 2027

Study information

Verified date February 2023
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We 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.


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 subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. We propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 138
Est. completion date May 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Rheopheresis procedure
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
Sham-apheresis
Sham-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.

Locations

Country Name City State
France Hop Claude Huriez Chu Lille Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
at 12 weeks of treatement
Secondary 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. At 4 weeks and 12 weeks of rheopheresis treatment.
Secondary Occurrence of new ulcerated calciphylaxis lesions Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment. At 4 weeks and 12 weeks of rheopheresis treatment.
Secondary 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 from baseline (V0) to 12 weeks of rheopheresis (V2)
Secondary 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.
from baseline (V0) to 12 weeks of rheopheresis (V2)
Secondary Number of days without antibiotics Number of days the patient receives antibiotics, regardless of the route of administration, whether the patient is treated on an outpatient or inpatient basis. during the 12 weeks of rheopheresis treatment
Secondary Quality of life by the Wound quality of life score (Wound-Qol) The Wound-QoL measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days. form baseline (V0) and at 12 weeks
Secondary Number of days discharged from hospital Number of days the patient is treated on an outpatient basis. during the 12 weeks of rheopheresis treatment
Secondary Overall survival Survival of patients, whether or not calciphylaxis is cured. at 12 weeks and 12 months after first rheopheresis.
Secondary Change in inflammatory proteins Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen. from baseline to 12 weeks-rheopheresis treatment
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