A Phase 3 interventional study of Vitamin K1 and Magnesium citrate in Calciphylaxis, sponsored by University of Sydney. Recruiting at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by University of Sydney · Phase 3, Interventional, and Treatment
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
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.
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's planned enrollment of 350 is above the median of 28 across 12 interventional studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Nil
Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate
Drug: Placebo injection (normal saline) · Drug: Placebo capsule (Vitamin K1) · Drug: Placebo tablet (Magnesium citrate)
Dose: 10mg Vitamin K1 capsules, administered 3 times per week following the subject's hemodialysis session. * Placebo Magnesium Citrate * Placebo Sodium Thiosulphate
Drug: Vitamin K1 · Drug: Placebo injection (normal saline) · Drug: Placebo tablet (Magnesium citrate)
Dose: 150mg Magnesium Citrate tablets, administered 3 times per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session. * Placebo Vitamin K1 * Placebo Sodium Thiosulphate
Drug: Magnesium citrate · Drug: Placebo injection (normal saline) · Drug: Placebo capsule (Vitamin K1)
Dose: 25g Sodium Thiosulfate injection, administered intravenously 3 times per week, during the subject's last hour of hemodialysis. * Placebo Vitamin K1 * Placebo Magnesium Citrate
Drug: Sodium Thiosulfate · Drug: Placebo capsule (Vitamin K1) · Drug: Placebo tablet (Magnesium citrate)
Hemodialysis using a high flux dialyser
Device: High Flux Dialyser
Hemodialysis using a medium cut-off dialyser
Device: Medium Cut-off Dialyser
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
Also known as: Phytonadione
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 injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Also known as: Intravenous Sodium Thiosulfate Injection
Hemodialysis using a high flux dialyser.
Also known as: High Flux Hemodialysis
Hemodialysis using a medium cut-off dialyser.
Also known as: Medium Cut-off Hemodialysis
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Also known as: 0.9% sodium chloride solution
Placebo to be administered 3 times per week following the subject's hemodialysis session.
Also known as: Matching placebo capsule
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.
Also known as: Matching placebo tablet
BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to 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
Time frame: Week 12
BEAT-Calci Wound Assessment Scale - Baseline to 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: 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
Time frame: Week 26
Distribution of each of the individual components of the BCWAS, assessed at Weeks 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: 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
Time frame: Week 4
Distribution of each of the individual components of the BCWAS, assessed at 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: 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
Time frame: Week 12
Distribution of each of the individual components of the BCWAS, assessed at 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: 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
Time frame: Week 26
Bates-Jensen Wound Assessment Tool - from Baseline to 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
Time frame: Week 4
Bates-Jensen Wound Assessment Tool - from Baseline to 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
Time frame: Week 12
Bates-Jensen Wound Assessment Tool - from Baseline to 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
Time frame: Week 26
Sentinel ulcer surface area - from Baseline, assessed at Week 4
To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 4
Time frame: Week 4
Sentinel ulcer surface area - from Baseline, assessed at Week 12
To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 12
Time frame: Week 12
Sentinel ulcer surface area - from Baseline, assessed at Week 26
To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 26
Time frame: Week 26
All ulcers total surface area - from Baseline, assessed at 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
Time frame: Week 4
All ulcers total surface area - from Baseline, assessed at 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
Time frame: Week 12
All ulcers total surface area - from Baseline, assessed at 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
Time frame: Week 26
Change over time of self-reported pain
To determine whether addition of the intervention changes self-reported pain over time, assessed using the 0-to-10 Numerical Rating Scale
Time frame: Week 26
Self-reported pain at 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
Time frame: Week 12
Change over time of analgesic use
To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 26
Time frame: Week 26
Analgesic use 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
Time frame: Week 12
Composite self-reported pain and analgesic use over time
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
Time frame: Week 26
Composite self-reported pain and analgesic use at 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
Time frame: Week 12
Change in self-reported quality of life from Baseline to 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
Time frame: Week 4
Change in self-reported quality of life from Baseline to 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
Time frame: Week 12
Change in self-reported quality of life from Baseline to 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
Time frame: Week 26
Time to first calciphylaxis-attributable infection from Baseline to Week 26
Time in days to first calciphylaxis-attributable infection within 26 weeks post-randomisation
Time frame: Week 26
All-cause hospitalisation days
Count of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisation
Time frame: Weeks 0-26
Mortality
Incidence of mortality, as derived from hospital reports, within 5-years post-randomisation
Time frame: Up to 5 years
Kidney Transplantation
Incidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisation
Time frame: Up to 5 years
Calciphylaxis recurrence
Incidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisation
Time frame: Up to 5 years
Plan to share: Yes — Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: To be confirmed
Access criteria: No data should be released that would compromise the trial, unless specifically for safety reasons. There must be a strong scientific or other legitimate rationale for the data to be used for the requested purpose. Investigators should have a period of exclusivity in which to pursue their aims with the data, before key trial data are made available to other researchers. Adequate resources must be available in order to comply with the request, and the scientific aims of the study must justify the use of such resources. Data release complies with the relevant regulations from all relevant countries.
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Studies of the drugs tested here: Vitamin K 1 · Magnesium citrate · Sodium thiosulfate
University of Sydney