Better Evidence And Translation for Calciphylaxis (BEAT-Calci)
The treatment of calciphylaxis is a critical unmet need, with no proven treatment options, considerable variation in clinical practice and a complete absence of randomised controlled trials. Expansion of the current evidence base is urgently needed. BEAT-Calci is an adaptive platform trial which will effectively and efficiently generate evidence as to the best treatments for calciphylaxis and maximise participant access to treatment options.
Adaptive, platform, randomised controlled trial, involving multiple interventions spanning several domains of therapeutic care. The trial will commence with a Dialysis Membrane Domain and Pharmacotherapy Domain.
Objective and Primary Outcome Measure
The objective of the study is to establish high-quality evidence on the effect of a range of interventions on the BEAT-Calci Wound Assessment Scale (BCWAS) in patients with kidney failure and newly diagnosed calciphylaxis. BCWAS, a score that incorporates clinically significant calciphylaxis events, will be used to determine each participant's outcome.
Patients with kidney failure and newly diagnosed calciphylaxis.
Main Eligibility Criteria
Main Eligibility Criteria Platform Inclusion Criteria:
- Age ≥ 18 years
- 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
- Have a new calciphylaxis ulcer present for less than 10 weeks
- Eligible for randomisation in at least one recruiting domain
- The participant and treating physician are willing and able to perform trial procedures
Platform Exclusion Criteria: Nil
Anticipated time to complete recruitment: 6 years
Active follow-up is for 26 weeks and passive follow-up is for 4.5 years.