NCT05018221

Better Evidence and Translation for Calciphylaxis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BEAT-Calci is a randomized, adaptive, multi-center, platform trial that will evaluate multiple interventions, across several domains of therapeutic care. The objective of the study is to establish high-quality evidence on the effect of a range of interventions in patients with kidney failure and newly diagnosed calciphylaxis. Calciphylaxis is a rare disease affecting 1-2 people in 10,000. The trial will commence with a Dialysis Membrane Domain and Pharmacotherapy Domain. The Pharmacotherapy Domain of BEAT-Calci is a placebo-controlled, double blind, response adaptive, randomised controlled trial that will investigate whether any of the pharmacotherapeutic agents is superior to placebo in improving outcomes. The Dialysis Membrane Domain of BEAT-Calci is an open-label, randomised controlled two-way comparison between two different dialysis technologies. The BEAT-Calci Wound Assessment Scale (BCWAS) is the primary endpoint for the trial. It is an 8-point ordinal categorical scale of disease outcomes and will be used to determine each participant's outcome. The trial will utilise a Bayesian adaptive sample size re-estimation approach for sample size calculations. The trial will continue to recruit until predefined superiority or futility rules are met. As the trial progresses, in response to information accumulating during the trial, there are various adaptations that can occur, including addition or removal of an intervention arm, response adaptive randomisation and addition of new therapeutic domains.

Conditions

• Calciphylaxis

Interventions

Type	Name	Description
DRUG	Vitamin K1	Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
DRUG	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.
DRUG	Sodium Thiosulfate	Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
DEVICE	High Flux Dialyser	Hemodialysis using a high flux dialyser.
DEVICE	Medium Cut-off Dialyser	Hemodialysis using a medium cut-off dialyser.
DRUG	Placebo injection (normal saline)	Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
DRUG	Placebo capsule (Vitamin K1)	Placebo to be administered 3 times per week following the subject's hemodialysis session.
DRUG	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.

Timeline

• Start date: 2021-08-26
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2021-08-24
• Last updated: 2025-08-13

Locations

21 sites across 2 countries: Australia, New Zealand