Rare Disease Trial, Recruiting NCT04654000 Sponsor: University Hospital, Lille Condition: Rare Disease
Back to Rare Disease

Rare Disease Trial, Recruiting

NCT04654000
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have a condition called calciphylaxis, with at least one wound that is open (ulcerated) or has tissue that has died (necrotic)
  • You have end-stage kidney disease and are currently receiving hemodialysis (kidney dialysis)
  • You weigh more than 30 kg (approximately 66 pounds)
  • You are covered by a social security or health insurance system
  • You are willing and able to sign a written consent form agreeing to take part
  • You may also be eligible if your calciphylaxis has been getting worse — developing open wounds or tissue death — despite already receiving standard treatment

Who may not be able to join:

  • Your overall physical ability and health is very severely reduced, based on a specific medical scoring scale (confirm with trial site)
  • Your doctor who specialises in dialysis estimates that, for reasons unrelated to calciphylaxis, you are not expected to live more than 6 months
  • You have an infection that cannot be controlled, meaning you still have a fever even after receiving appropriate antibiotic treatment
  • You have a condition called common variable immunodeficiency, which affects how your immune system works
  • You have a known allergy to albumin (a protein used in some medical treatments)
  • You are taking a type of blood-thinning medication called anti-vitamin K, and it would not be safe for you to stop taking it
  • You have severe cognitive (thinking/memory) or psychiatric (mental health) difficulties that prevent you from giving informed consent, or you are unwilling to participate
  • You are pregnant or breastfeeding
  • You are under legal supervision, are hospitalised without your consent, are living in a care facility where you are receiving care rather than participating in research, or are in an emergency situation (these are specific protections under French health law)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Arnaud Lionet, MD, University Hospital, Lille

Phone: 0320445000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
7 March 2023
Est. completion
1 April 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov