Better Evidence and Translation for Calciphylaxis

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborators: Australasian Kidney Trials Network; Salford Royal NHS Foundation Trust; Waitemata District Health Board
• Treatments: Citric Acid; Magnesium citrate; Sodium Citrate; Sodium thiosulfate; Vitamin K; Vitamin K 1; Vitamins

Criteria

Inclusion Criteria:

1. 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

2. Have a new calciphylaxis ulcer present for less than 10 weeks

3. Age ≥ 18 years

4. Eligible for randomisation in at least one recruiting domain

5. The participant and treating physician are willing and able to perform trial procedures

Exclusion Criteria:

Nil