Rheopheresis as Adjuvant Treatment of Calciphylaxis (RHEO-CAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04654000|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Disorder End Stage Renal Disease Rare Diseases||Procedure: Rheopheresis procedure Procedure: Sham-apheresis||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||April 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Rheopheresis group
In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages:
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 Comparator: Sham-apheresis group
In addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group.
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.
- Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions). [ Time Frame: at 12 weeks of treatement ]
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.
- Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment. [ Time Frame: At 4 weeks and 12 weeks of 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.
- Occurrence of new ulcerated calciphylaxis lesions [ Time Frame: At 4 weeks and 12 weeks of rheopheresis treatment. ]Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment.
- Evolution of the self-reporting pain using Numeric Rating Scale (NRS) [ Time Frame: from baseline (V0) to 12 weeks of rheopheresis (V2) ]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
- Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification [ Time Frame: from baseline (V0) to 12 weeks of rheopheresis (V2) ]
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.
- Number of days without antibiotics [ Time Frame: during the 12 weeks of rheopheresis treatment ]Number of days the patient receives antibiotics, regardless of the route of administration, whether the patient is treated on an outpatient or inpatient basis.
- Quality of life by the Wound quality of life score (Wound-Qol) [ Time Frame: form baseline (V0) and at 12 weeks ]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.
- Number of days discharged from hospital [ Time Frame: during the 12 weeks of rheopheresis treatment ]Number of days the patient is treated on an outpatient basis.
- Overall survival [ Time Frame: at 12 weeks and 12 months after first rheopheresis. ]Survival of patients, whether or not calciphylaxis is cured.
- Change in inflammatory proteins [ Time Frame: from baseline to 12 weeks-rheopheresis treatment ]Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654000
|Contact: Arnaud Lionet, MD||0320445000 ext +firstname.lastname@example.org|
|Principal Investigator:||Arnaud Lionet, MD||University Hospital, Lille|