Better Evidence and Translation for Calciphylaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin K1, Magnesium citrate, Sodium Thiosulfate, High Flux Dialyser.
- Who it may be relevant to
- Registry conditions: Calciphylaxis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12 [Time frame: Week 12]
Secondary outcome measures (12)
- BEAT-Calci Wound Assessment Scale - Baseline to Week 26 [Time frame: Week 26]
- Distribution of each of the individual components of the BCWAS, assessed at Weeks 4 [Time frame: Week 4]
- Distribution of each of the individual components of the BCWAS, assessed at Week 12 [Time frame: Week 12]
- Distribution of each of the individual components of the BCWAS, assessed at Week 26 [Time frame: Week 26]
- Bates-Jensen Wound Assessment Tool - from Baseline to Week 4 [Time frame: Week 4]
- Bates-Jensen Wound Assessment Tool - from Baseline to Week 12 [Time frame: Week 12]
- Bates-Jensen Wound Assessment Tool - from Baseline to Week 26 [Time frame: Week 26]
- Sentinel ulcer surface area - from Baseline, assessed at Week 4 [Time frame: Week 4]
- Sentinel ulcer surface area - from Baseline, assessed at Week 12 [Time frame: Week 12]
- Sentinel ulcer surface area - from Baseline, assessed at Week 26 [Time frame: Week 26]
- All ulcers total surface area - from Baseline, assessed at Week 4 [Time frame: Week 4]
- All ulcers total surface area - from Baseline, assessed at Week 12 [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- 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 criteria
Nil
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 16 centers
- Concord Repatriation General Hospital — Concord
- St George Hospital — Kogarah
- Liverpool Hospital — Liverpool
- John Hunter Hospital — New Lambton Heights
- Westmead Hospital — Westmead
- Sunshine Coast Hospital and Health Service — Birtinya
- Princess Alexandra Hospital — Brisbane
- Bundaberg Base Hospital — Bundaberg
- … and 8 more centers
New Zealand · 5 centers
- Dunedin Hospital — Dunedin
- Auckland City Hospital (Auckland DHB) — Grafton
- North Shore Hospital (Waitemata DHB) — Takapuna
- Tauranga Hospital — Tauranga
- Whangarei Hospital — Whangarei
Publications
- Krishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available. PMID 39186385
Identifiers
NCT: NCT05018221 · BEAT-Calci