Better Evidence and Translation for Calciphylaxis
ConditionCalciphylaxis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
Eligibility criteria
Qualifiers
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
Age ≥ 18 years
Eligible for randomisation in at least one recruiting domain
Disqualifiers
None
Trial design
Treatments tested in this trial
- Vitamin K1
- Magnesium citrate
- Sodium Thiosulfate
- High Flux Dialyser
- Medium Cut-off Dialyser
- Placebo injection (normal saline)
- Placebo capsule (Vitamin K1)
- Placebo tablet (Magnesium citrate)
Treatment groups
350 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
21Australia
Concord Repatriation General Hospital ConcordNew South Wales, Australia
St George Hospital KogarahNew South Wales, Australia
Liverpool Hospital2170, LiverpoolNew South Wales, Australia
John Hunter Hospital2305, New Lambton HeightsNew South Wales, Australia
Sponsors and collaborators
University of Sydney
Lead sponsor
Australasian Kidney Trials Network
Collaborator
Northern Care Alliance NHS Foundation Trust
Collaborator
Waitemata District Health Board
Collaborator
Vantive Health LLC
Collaborator
Berry Consultants
Collaborator
Source ClinicalTrials.gov