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NCT Number: NCT05018221

Better Evidence and Translation for Calciphylaxis

This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.

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Key information

Conditions

Calciphylaxis Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K1

Drug

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

Other names: Phytonadione

Magnesium citrate

Drug

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

Drug

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

Other names: Intravenous Sodium Thiosulfate Injection

High Flux Dialyser

Device

Hemodialysis using a high flux dialyser.

Other names: High Flux Hemodialysis

Medium Cut-off Dialyser

Device

Hemodialysis using a medium cut-off dialyser.

Other names: Medium Cut-off Hemodialysis

Placebo injection (normal saline)

Drug

Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

Other names: 0.9% sodium chloride solution

Placebo capsule (Vitamin K1)

Drug

Placebo to be administered 3 times per week following the subject's hemodialysis session.

Other names: Matching placebo capsule

Placebo tablet (Magnesium citrate)

Drug

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.

Other names: Matching placebo tablet

Primary outcomes

  1. BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12

    Time frame: 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:

    • Complete epithelialisation of the sentinel ulcer
    • >50% reduction in sentinel ulcer surface area
    • 20-50% reduction in sentinel ulcer surface area
    • 0-20% reduction in sentinel ulcer surface area
    • Any increase in sentinel ulcer surface area
    • Development of new ulcers
    • Amputation due to an ulcer
    • All-cause death

Secondary outcomes

  1. BEAT-Calci Wound Assessment Scale - Baseline to Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes the sentinel ulcer from Baseline to Week 26 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:

    • Complete epithelialisation of the sentinel ulcer
    • >50% reduction in sentinel ulcer surface area
    • 20-50% reduction in sentinel ulcer surface area
    • 0-20% reduction in sentinel ulcer surface area
    • Any increase in sentinel ulcer surface area
    • Development of new ulcers
    • Amputation due to an ulcer
    • All-cause death

  2. Distribution of each of the individual components of the BCWAS, assessed at Weeks 4

    Time frame: Week 4

    To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Weeks 4

    Scale described as:

    • Complete epithelialisation of the sentinel ulcer
    • >50% reduction in sentinel ulcer surface area
    • 20-50% reduction in sentinel ulcer surface area
    • 0-20% reduction in sentinel ulcer surface area
    • Any increase in sentinel ulcer surface area
    • Development of new ulcers
    • Amputation due to an ulcer
    • All-cause death

  3. Distribution of each of the individual components of the BCWAS, assessed at Week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Week 12

    Scale described as:

    • Complete epithelialisation of the sentinel ulcer
    • >50% reduction in sentinel ulcer surface area
    • 20-50% reduction in sentinel ulcer surface area
    • 0-20% reduction in sentinel ulcer surface area
    • Any increase in sentinel ulcer surface area
    • Development of new ulcers
    • Amputation due to an ulcer
    • All-cause death

  4. Distribution of each of the individual components of the BCWAS, assessed at Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Week 26.

    Scale described as:

    • Complete epithelialisation of the sentinel ulcer
    • >50% reduction in sentinel ulcer surface area
    • 20-50% reduction in sentinel ulcer surface area
    • 0-20% reduction in sentinel ulcer surface area
    • Any increase in sentinel ulcer surface area
    • Development of new ulcers
    • Amputation due to an ulcer
    • All-cause death

  5. Bates-Jensen Wound Assessment Tool - from Baseline to Week 4

    Time frame: Week 4

    To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 4 using the Bates-Jensen Wound Assessment Tool

  6. Bates-Jensen Wound Assessment Tool - from Baseline to Week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 12, using the Bates-Jensen Wound Assessment Tool

  7. Bates-Jensen Wound Assessment Tool - from Baseline to Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 26, using the Bates-Jensen Wound Assessment Tool

  8. Sentinel ulcer surface area - from Baseline, assessed at Week 4

    Time frame: Week 4

    To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 4

  9. Sentinel ulcer surface area - from Baseline, assessed at Week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 12

  10. Sentinel ulcer surface area - from Baseline, assessed at Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 26

  11. All ulcers total surface area - from Baseline, assessed at Week 4

    Time frame: Week 4

    To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 4

  12. All ulcers total surface area - from Baseline, assessed at Week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 12

  13. All ulcers total surface area - from Baseline, assessed at Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 26

  14. Change over time of self-reported pain

    Time frame: Week 26

    To determine whether addition of the intervention changes self-reported pain over time, assessed using the 0-to-10 Numerical Rating Scale

  15. Self-reported pain at week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes self-reported pain use at week 12 assessed using the 0-to-10 Numerical Rating Scale

  16. Change over time of analgesic use

    Time frame: Week 26

    To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 26

  17. Analgesic use week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 12

  18. Composite self-reported pain and analgesic use over time

    Time frame: Week 26

    To determine whether addition of the intervention changes the composite outcome of self-reported pain (assessed using the 0-to-10 Numerical Rating Scale) and analgesic use over time

  19. Composite self-reported pain and analgesic use at week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes the composite outcome of self-reported pain (assessed using the 0-to-10 Numerical Rating Scale) and analgesic use at week 12

  20. Change in self-reported quality of life from Baseline to Week 4

    Time frame: Week 4

    To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 4, using the EuroQoL EQ-5D-5L instrument

  21. Change in self-reported quality of life from Baseline to Week 12

    Time frame: Week 12

    To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 12, using the EuroQoL EQ-5D-5L instrument

  22. Change in self-reported quality of life from Baseline to Week 26

    Time frame: Week 26

    To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 26 using the EuroQoL EQ-5D-5L instrument

  23. Time to first calciphylaxis-attributable infection from Baseline to Week 26

    Time frame: Week 26

    Time in days to first calciphylaxis-attributable infection within 26 weeks post-randomisation

  24. All-cause hospitalisation days

    Time frame: Weeks 0-26

    Count of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisation

  25. Mortality

    Time frame: Up to 5 years

    Incidence of mortality, as derived from hospital reports, within 5-years post-randomisation

  26. Kidney Transplantation

    Time frame: Up to 5 years

    Incidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisation

  27. Calciphylaxis recurrence

    Time frame: Up to 5 years

    Incidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisation

Study contacts

Contact information is provided by the study sponsor or research team.

Meg Jardine

CONTACT

[email protected]

9562 5000

Sibyl Masterman

CONTACT

[email protected]

8036 5272

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Australasian Kidney Trials Network
  • Berry Consultants
  • Northern Care Alliance NHS Foundation Trust
  • Vantive Health LLC
  • Waitemata District Health Board

Registry information

Acronym: BEAT-Calci

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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