Better Evidence and Translation for Calciphylaxis

Condition(s) studied

Investigational drug(s) / intervention(s)

Vitamin K1: Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.

Magnesium citrate: 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: Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

High Flux Dialyser: Hemodialysis using a high flux dialyser.

Medium Cut-off Dialyser: Hemodialysis using a medium cut-off dialyser.

Placebo injection (normal saline): Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

Placebo capsule (Vitamin K1): Placebo to be administered 3 times per week following the subject's hemodialysis session.

Placebo tablet (Magnesium citrate): 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.

Study 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

Primary outcome measure(s)

• BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12 — Week 12
  To determine whether addition of the intervention changes the sentinel ulcer from Baseline to Week 12 on the BEAT-Calci Wound Assessment Scale. This is an 8-point ordinal categorical scale of change since baseline, which will be used to determine each participant's outcome. The scale is described as: 1. Complete epithelialisation of the sentinel ulcer 2. \>50% reduction in sentinel ulcer surface area 3. 20-50% reduction in sentinel ulcer surface area 4. 0-20% reduction in sentinel ulcer surface area 5. Any increase in sentinel ulcer surface area 6. Development of new ulcers 7. Amputation due to an ulcer 8. All-cause death

Trial sites (21)

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