CalciphylaxisPhase 3BEAT-CalciNCT05018221
Better Evidence and Translation for Calciphylaxis
A Phase 3 study testing Vitamin K1, Magnesium citrate and Sodium Thiosulfate in people with Calciphylaxis, run by University of Sydney at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calciphylaxis
- What is being tested?
- Vitamin K1, Magnesium citrate and Sodium Thiosulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 26 Aug 2021to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nil
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
Australia16 sites, 16 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide
Michael Collins
- Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland
Rathika Krishnasamy
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland
Carmel Hawley
- Recruiting
Bundaberg Base Hospital
Bundaberg, Queensland
Clyson Mutatiri
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
Catherine Wilkinson, +610742269970, Catherine.Wilkinson@health.qld.gov.au
- Recruiting
Monash Medical Centre
Clayton
Peter Kerr
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales
Angus Ritchie
- Recruiting
Townsville Hospital
Douglas, Queensland, 4814
Vikas Srivastava, +61744332650, vikas.srivastava@health.qld.gov.au
- Recruiting
Ipswich Hospital
Ipswich, Queensland, 4305
Sree Venuthurupalli, +61 7 4616 6451, sree.venuthurupalli@health.qld.gov.au
- Recruiting
St George Hospital
Kogarah, New South Wales
Brendan Smyth
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Angela Makris, + 61287383719, angela.makris@health.nsw.gov.au
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria
Irene Ruderman
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Pedro Gois, +61249213545, pedro.francagois@health.nsw.gov.au
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Hemant Kulkarni, +61894676361, Hemant.Kulkarni@health.wa.gov.au
- Recruiting
Sunshine Hospital (Western Health)
St Albans, Victoria
Eugenia Pedagogos
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Grahame Elder, +61288906962, grahame.j.elder@gmail.com
New Zealand5 sites, 5 recruiting
- Recruiting
Dunedin Hospital
Dunedin
Rob Walker
- Recruiting
Auckland City Hospital (Auckland DHB)
Grafton
Tze Goh
- Recruiting
North Shore Hospital (Waitemata DHB)
Takapuna
Janak de Zoysa
- Recruiting
Tauranga Hospital
Tauranga
Gavin McHaffie
- Recruiting
Whangarei Hospital
Whangarei
Sharen Supershad
About this study
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
Read the 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
- Being tested
- Vitamin K1, Magnesium citrate, Sodium Thiosulfate, High Flux Dialyser, Medium Cut-off Dialyser
- Medical subject headings
- Calciphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K1Drug
Also called Phytonadione
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
Magnesium citrateDrug
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 ThiosulfateDrug
Also called Intravenous Sodium Thiosulfate Injection
Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
High Flux DialyserDevice
Also called High Flux Hemodialysis
Hemodialysis using a high flux dialyser.
Medium Cut-off DialyserDevice
Also called Medium Cut-off Hemodialysis
Hemodialysis using a medium cut-off dialyser.
Placebo injection (normal saline)Drug
Also called 0.9% sodium chloride solution
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Placebo capsule (Vitamin K1)Drug
Also called Matching placebo capsule
Placebo to be administered 3 times per week following the subject's hemodialysis session.
Placebo tablet (Magnesium citrate)Drug
Also called Matching placebo tablet
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Double-Blind Period) | Placebo comparator | Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate Receives: Drug: Placebo injection (normal saline); Drug: Placebo capsule (Vitamin K1); Drug: Placebo tablet (Magnesium citrate) |
| Vitamin K1 (Double-Blind Period) | Experimental | Dose: 10mg Vitamin K1 capsules, administered 3 times per week following the subject's hemodialysis session.
* Placebo Magnesium Citrate
* Placebo Sodium Thiosulphate Receives: Drug: Vitamin K1; Drug: Placebo injection (normal saline); Drug: Placebo tablet (Magnesium citrate) |
| Magnesium Citrate (Double-Blind Period) | Experimental | 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 Receives: Drug: Magnesium citrate; Drug: Placebo injection (normal saline); Drug: Placebo capsule (Vitamin K1) |
| Sodium Thiosulfate (Double-Blind Period) | Experimental | 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 Receives: Drug: Sodium Thiosulfate; Drug: Placebo capsule (Vitamin K1); Drug: Placebo tablet (Magnesium citrate) |
| High Flux Hemodialysis | Active comparator | Hemodialysis using a high flux dialyser Receives: Device: High Flux Dialyser |
| Medium Cut-off Hemodialysis | Experimental | Hemodialysis using a medium cut-off dialyser Receives: Device: Medium Cut-off Dialyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: Week 12
Secondary outcomes (27)
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:
- 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
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 26
All-cause hospitalisation days
Count of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisation
Measured: Weeks 0-26
Mortality
Incidence of mortality, as derived from hospital reports, within 5-years post-randomisation
Measured: Up to 5 years
Kidney Transplantation
Incidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisation
Measured: Up to 5 years
Calciphylaxis recurrence
Incidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisation
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start26 Aug 2021
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Adaptive, platform, randomized controlled trial, involving multiple interventions spanning several domains of therapeutic care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Kidney Trials Network, Northern Care Alliance NHS Foundation Trust, Waitemata District Health Board, Vantive Health LLC, Berry Consultants
- Responsible party
- Sponsor
- Investigators
- Meg Jardine, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018221
- Sponsor's protocol ID
- BEAT-Calci
- Acronym
- BEAT-Calci
- Status last verified
- Jun 2025
- First submitted
- 9 Aug 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 39186385
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Evidence and Translation for Calciphylaxis
- ClinicalTrials.gov ID
- NCT05018221
- Acronym / sponsor ID
- BEAT-Calci / BEAT-Calci
- Conditions
- Calciphylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Australasian Kidney Trials Network, Northern Care Alliance NHS Foundation Trust, Waitemata District Health Board, Vantive Health LLC, Berry Consultants
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Adaptive, platform, randomized controlled trial, involving multiple interventions spanning several domains of therapeutic care.
| Arm | Type | Receives |
|---|---|---|
| Placebo (Double-Blind Period) | Placebo comparator | Drug: Placebo injection (normal saline), Drug: Placebo capsule (Vitamin K1), Drug: Placebo tablet (Magnesium citrate)Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate |
| Vitamin K1 (Double-Blind Period) | Experimental | Drug: Vitamin K1, Drug: Placebo injection (normal saline), 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 |
| Magnesium Citrate (Double-Blind Period) | Experimental | Drug: Magnesium citrate, Drug: Placebo injection (normal saline), Drug: Placebo capsule (Vitamin K1)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 |
| Sodium Thiosulfate (Double-Blind Period) | Experimental | Drug: Sodium Thiosulfate, Drug: Placebo capsule (Vitamin K1), Drug: Placebo tablet (Magnesium citrate)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 |
| High Flux Hemodialysis | Active comparator | Device: High Flux DialyserHemodialysis using a high flux dialyser |
| Medium Cut-off Hemodialysis | Experimental | Device: Medium Cut-off DialyserHemodialysis using a medium cut-off dialyser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K1Also: PhytonadioneVitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session. | Drug | Vitamin K1 (Double-Blind Period) |
| Magnesium citrateMagnesium 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 | Magnesium Citrate (Double-Blind Period) |
| Sodium ThiosulfateAlso: Intravenous Sodium Thiosulfate InjectionSodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis. | Drug | Sodium Thiosulfate (Double-Blind Period) |
| High Flux DialyserAlso: High Flux HemodialysisHemodialysis using a high flux dialyser. | Device | High Flux Hemodialysis |
| Medium Cut-off DialyserAlso: Medium Cut-off HemodialysisHemodialysis using a medium cut-off dialyser. | Device | Medium Cut-off Hemodialysis |
| Placebo injection (normal saline)Also: 0.9% sodium chloride solutionPlacebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis. | Drug | Magnesium Citrate (Double-Blind Period), Placebo (Double-Blind Period), Vitamin K1 (Double-Blind Period) |
| Placebo capsule (Vitamin K1)Also: Matching placebo capsulePlacebo to be administered 3 times per week following the subject's hemodialysis session. | Drug | Magnesium Citrate (Double-Blind Period), Placebo (Double-Blind Period), Sodium Thiosulfate (Double-Blind Period) |
| Placebo tablet (Magnesium citrate)Also: Matching placebo tabletPlacebo to be administered 3 times per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session. | Drug | Placebo (Double-Blind Period), Sodium Thiosulfate (Double-Blind Period), Vitamin K1 (Double-Blind Period) |
Primary outcome
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: 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
27 secondary outcomes
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
All ulcers total surface area - from Baseline, assessed at Week 26
Time frame: Week 26
Change over time of self-reported pain
Time frame: Week 26
Self-reported pain at week 12
Time frame: Week 12
Change over time of analgesic use
Time frame: Week 26
Analgesic use week 12
Time frame: Week 12
Composite self-reported pain and analgesic use over time
Time frame: Week 26
Composite self-reported pain and analgesic use at week 12
Time frame: Week 12
Change in self-reported quality of life from Baseline to Week 4
Time frame: Week 4
Change in self-reported quality of life from Baseline to Week 12
Time frame: Week 12
Change in self-reported quality of life from Baseline to Week 26
Time frame: Week 26
Time to first calciphylaxis-attributable infection from Baseline to Week 26
Time frame: Week 26
All-cause hospitalisation days
Time frame: Weeks 0-26
Mortality
Time frame: Up to 5 years
Kidney Transplantation
Time frame: Up to 5 years
Calciphylaxis recurrence
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 39186385Krishnasamy 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.
- Individual participant dataSharing planned: 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.
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Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 1
Anti-Interleukin-6 (IL6) in Calciphylaxis
Calciphylaxis
RecruitingObservational study
Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
Calciphylaxis, Calcific Uremic Arteriolopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meg Jardine study chair
University of Sydney
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin K1, Magnesium citrate and Sodium Thiosulfate in people with Calciphylaxis, run by University of Sydney at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibyl Masterman (8036 5272, sibyl.masterman@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.