Better Evidence and Translation for Calciphylaxis
University of Sydney
350 participants
Aug 26, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
- The participant and treating physician are willing and able to perform trial procedures
Exclusion Criteria1
- Nil
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Interventions
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
Magnesium Citrate tablet (150mg) to be administered 3 times per per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session.
Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Hemodialysis using a high flux dialyser.
Hemodialysis using a medium cut-off dialyser.
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Placebo to be administered 3 times per week following the subject's hemodialysis session.
Placebo to be administered 3 times per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session.
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05018221