End Stage Renal Disease Clinical Trial
— RHEO-CALOfficial title:
Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Verified date | February 2023 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Hop Claude Huriez Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Ministry of Health, France |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04076488 -
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
|
N/A | |
Completed |
NCT03289650 -
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
|
Phase 3 | |
Completed |
NCT04042324 -
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01242904 -
Use of a Bimodal Solution for Peritoneal Dialysis
|
Phase 2 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03257410 -
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A | |
Withdrawn |
NCT02130817 -
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
Phase 4 | |
Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
Recruiting |
NCT02176434 -
Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
|
N/A | |
Active, not recruiting |
NCT02581449 -
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
|
Phase 2 | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Completed |
NCT02830490 -
Reliability of Functional Measures in Hemodialysis Patient.
|
N/A | |
Completed |
NCT02215655 -
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
|
N/A | |
Completed |
NCT02832466 -
Quantifying the Deterioration of Physical Function in Renal Patients
|
N/A | |
Completed |
NCT02832440 -
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
|
N/A | |
Recruiting |
NCT01912001 -
Virtual Ward for Home Dialysis
|
N/A |