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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02896-33 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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.
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. The investigators 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheopheresis group | Experimental | In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages:
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| Sham-apheresis group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rheopheresis procedure | Procedure | rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
A patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Lionet, MD | Contact | 0320445000 | +33 | arnaud.lionet@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Lionet, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Not yet recruiting | Angers | 49933 | France |
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| Sham-apheresis | Procedure | 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. |
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| At 4 weeks and 12 weeks of rheopheresis treatment. |
| 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. |
| 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) |
| 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
| from baseline (V0) to 12 weeks of rheopheresis (V2) |
| 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 |
| 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 |
| Number of days discharged from hospital | Number of days the patient is treated on an outpatient basis. | during the 12 weeks of rheopheresis treatment |
| Overall survival | Survival of patients, whether or not calciphylaxis is cured. | at 12 weeks and 12 months after first rheopheresis. |
| Change in inflammatory proteins | Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen. | from baseline to 12 weeks-rheopheresis treatment |
| CHU d'Arras | Recruiting | Arras | 62022 | France |
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| CHU d'Auxerre | Not yet recruiting | Auxerre | 89011 | France |
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| CHU de Besançon, Hôpital Jean Minjoz | Recruiting | Besançon | 25000 | France |
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| CH de Béthune | Recruiting | Béthune | 62408 | France |
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| CH de Boulogne sur Mer | Recruiting | Boulogne-sur-Mer | 62321 | France |
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| CHU de Bordeaux | Not yet recruiting | Bourdeaux | 33076 | France |
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| CHRU de Brest | Not yet recruiting | Brest | 29609 | France |
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| CHU de Caen | Not yet recruiting | Caen | 14033 | France |
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| Hôpital Nord Michallon, CHU de Grenoble | Recruiting | Grenoble | 38043 | France |
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| Centre ECHO Laval | Recruiting | Laval | 53015 | France |
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| Centre ECHO Le Mans | Recruiting | Le Mans | 72000 | France |
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| Hôpital Privé La Louvière | Recruiting | Lille | 59000 | France |
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| Hop Claude Huriez Chu Lille | Recruiting | Lille | France |
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| CHR de Limoges | Recruiting | Limoges | 87042 | France |
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| Hôpital Lyon Sud | Not yet recruiting | Lyon | 69495 | France |
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| Hôpital Saint Joseph Saint Luc | Not yet recruiting | Lyon | 69635 | France |
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| Institut Phocéen de Néphrologie - Clinique Bouchard | Not yet recruiting | Marseille | 13006 | France |
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| Hôpital de la Conception, AP-HM | Recruiting | Marseille | 13385 | France |
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| CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
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| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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| CH de Niort | Not yet recruiting | Niort | 79000 | France |
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| CHU de Reims | Recruiting | Reims | 51092 | France |
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| CHU de Toulouse | Recruiting | Toulouse | 31059 | France |
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| Clinique Saint Exupéry | Not yet recruiting | Toulouse | 31400 | France |
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| CH de Valenciennes | Recruiting | Valenciennes | 59300 | France |
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| CHRU de Nancy Brabois | Not yet recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| Centre Hospitalier Bretagne Atlantique | Not yet recruiting | Vannes | 56017 | France |
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| CH de Vichy | Not yet recruiting | Vichy | 03200 | France |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D007676 | Kidney Failure, Chronic |
| D035583 | Rare Diseases |
| D002115 | Calciphylaxis |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
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