Better Evidence and Translation for Calciphylaxis
BEAT-Calci
1 other identifier
interventional
350
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2021
Longer than P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedStudy Start
First participant enrolled
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 13, 2025
June 1, 2025
8.3 years
August 9, 2021
August 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 12
Secondary Outcomes (27)
BEAT-Calci Wound Assessment Scale - Baseline to Week 26
Week 26
Distribution of each of the individual components of the BCWAS, assessed at Weeks 4
Week 4
Distribution of each of the individual components of the BCWAS, assessed at Week 12
Week 12
Distribution of each of the individual components of the BCWAS, assessed at Week 26
Week 26
Bates-Jensen Wound Assessment Tool - from Baseline to Week 4
Week 4
- +22 more secondary outcomes
Study Arms (6)
Placebo (Double-Blind Period)
PLACEBO COMPARATORPlacebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate
Vitamin K1 (Double-Blind Period)
EXPERIMENTALDose: 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)
EXPERIMENTALDose: 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)
EXPERIMENTALDose: 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 COMPARATORHemodialysis using a high flux dialyser
Medium Cut-off Hemodialysis
EXPERIMENTALHemodialysis using a medium cut-off dialyser
Interventions
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
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.
Hemodialysis using a high flux dialyser.
Hemodialysis using a medium cut-off dialyser.
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Placebo to be administered 3 times per week following the subject's hemodialysis session.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Nil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sydneylead
- Australasian Kidney Trials Networkcollaborator
- Northern Care Alliance NHS Foundation Trustcollaborator
- Waitemata District Health Boardcollaborator
- Vantive Health LLCcollaborator
- Berry Consultantscollaborator
Study Sites (21)
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Bundaberg Base Hospital
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Ipswich Hospital
Ipswich, Queensland, 4305, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Sunshine Hospital (Western Health)
St Albans, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Royal Adelaide Hospital
Adelaide, Australia
Monash Medical Centre
Clayton, Australia
Dunedin Hospital
Dunedin, New Zealand
Auckland City Hospital (Auckland DHB)
Grafton, New Zealand
North Shore Hospital (Waitemata DHB)
Takapuna, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Whangarei Hospital
Whangarei, New Zealand
Related Publications (1)
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: 39186385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Meg Jardine
University of Sydney
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinding of all parties will not be possible for all domains. The default position of the BEAT-Calci platform is that treatments determined by randomization will be blinded to as high a level is feasible. Within practical domains, a blind will be adopted, whereby participants, site personnel, trial investigators and outcome assessors will remain blinded to the treatment from the time of randomization until database lock of the comparisons to which that participant is contributing data. In blinded domains, randomization data will not be accessible by anyone else involved in the trial with the following exceptions: (1) data managers who work on the randomization and drug management system, (2) unblinded statistician(s) involved with the response adaptive randomization, and (3) the unblinded biostatistician who prepares reports for the IDMC. Information on the blind, or lack thereof, per domain will be described in the respective Domain-Specific Appendix.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 24, 2021
Study Start
August 26, 2021
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
August 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- 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.
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.