Better Evidence and Translation for Calciphylaxis
In plain words A Phase 3 study of vitamin K1 in people 18 and older, run by University of Sydney. It plans to enroll about 350 people at 21 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Calciphylaxis.
- 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…
- Have a new calciphylaxis ulcer present for less than 10 weeks
- Age ≥ 18 years
- Eligible for randomisation in at least one recruiting domain
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
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)
Registered summary
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
Where, as registered
No US site; Australia (16), New Zealand (5).