Evaluating treatments for calciphylaxis in kidney failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global platform study, known as BEAT-Calci, aims to evaluate various interventions for adult patients with kidney failure and newly diagnosed calciphylaxis. It is a randomized, adaptive, multi-center trial that will assess the effectiveness of pharmacotherapy and dialysis technologies. The study will utilize a Bayesian adaptive sample size approach and will continue to recruit participants until specific superiority or futility criteria are met. The primary endpoint is the BEAT-Calci Wound Assessment Scale, which measures disease outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Currently receiving haemodialysis, or peritoneal dialysis that can be converted to haemodialysis, with planned ongoing haemodialysis a minimum of three times per week for at least the duration of the protocolised calciphylaxis treatments within this trial
2. Have a new calciphylaxis ulcer present for less than 10 weeks
3. Age ≥ 18 years
4. Eligible for randomisation in at least one recruiting domain
5. The participant and treating physician are willing and able to perform trial procedures

Exclusion Criteria:

Nil

Where it's running

• Concord Repatriation General Hospital
  Concord, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• John Hunter Hospital
  New Lambton Heights, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Sunshine Coast Hospital and Health Service
  Birtinya, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Sibyl Masterman
• Email: sibyl.masterman@sydney.edu.au
• Phone: 8036 5272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Calciphylaxis in people with chronic kidney disease: causes, risks, and early signs

  This project will compare adults with chronic kidney disease who develop calciphylaxis to matched CKD patients who do not, collecting clinical data and biological samples to try to find risk factors and early signs.

  Recruiting Odense University Hospital · Odense · NCT07511283

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

• Human amniotic-derived mesenchymal stem cell treatment for calciphylaxis

  This will try human amniotic-derived mesenchymal stem cells as a treatment for adults 18–75 who have calciphylaxis, including people with chronic kidney disease whether they are on dialysis or not.

  Recruiting Early Phase 1 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT04592640

• Biobank for calciphylaxis research

  This study is collecting patient samples to learn more about calciphylaxis, a rare condition that causes painful skin sores, in hopes of finding better treatments.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT03032835

• Registry of Chronic Wounds and Ulcers

  This study collects information from patients with chronic wounds and ulcers to see how well different treatments are working and to improve the quality of wound care.

  Recruiting U.S. Wound Registry · The Woodlands, Texas · NCT02280733

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.