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| Name | Class |
|---|---|
| Australasian Kidney Trials Network | NETWORK |
| Northern Care Alliance NHS Foundation Trust | OTHER |
| Waitemata District Health Board | OTHER_GOV |
| Vantive Health LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Double-Blind Period) | Placebo Comparator | Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate |
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| Vitamin K1 (Double-Blind Period) | Experimental | Dose: 10mg Vitamin K1 capsules, administered 3 times per week following the subject's hemodialysis session.
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| 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.
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| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K1 | Drug | Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
Nil
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sibyl Masterman | Contact | 8036 5272 | sibyl.masterman@sydney.edu.au | |
| Meg Jardine | Contact | 9562 5000 | meg.jardine@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Meg Jardine | University of Sydney | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Repatriation General Hospital | Recruiting | Concord | New South Wales | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39186385 | Derived | 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. |
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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.
To be confirmed
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| INDUSTRY |
| Berry Consultants | OTHER |
Adaptive, platform, randomized controlled trial, involving multiple interventions spanning several domains of therapeutic care.
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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.
| High Flux Hemodialysis | Active Comparator | Hemodialysis using a high flux dialyser |
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| Medium Cut-off Hemodialysis | Experimental | Hemodialysis using a medium cut-off dialyser |
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| 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. |
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| Sodium Thiosulfate | Drug | Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis. |
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| High Flux Dialyser | Device | Hemodialysis using a high flux dialyser. |
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| Medium Cut-off Dialyser | Device | Hemodialysis using a medium cut-off dialyser. |
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| Placebo injection (normal saline) | Drug | Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis. |
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| Placebo capsule (Vitamin K1) | Drug | Placebo to be administered 3 times per week following the subject's hemodialysis session. |
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| 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. |
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| 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:
| 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:
| 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:
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 26 |
| All-cause hospitalisation days | Count of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisation | Weeks 0-26 |
| Mortality | Incidence of mortality, as derived from hospital reports, within 5-years post-randomisation | Up to 5 years |
| Kidney Transplantation | Incidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisation | Up to 5 years |
| Calciphylaxis recurrence | Incidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisation | Up to 5 years |
| St George Hospital | Recruiting | Kogarah | New South Wales | Australia |
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| Liverpool Hospital | Recruiting | Liverpool | New South Wales | 2170 | Australia |
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| John Hunter Hospital | Recruiting | New Lambton Heights | New South Wales | 2305 | Australia |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Sunshine Coast Hospital and Health Service | Recruiting | Birtinya | Queensland | Australia |
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| Princess Alexandra Hospital | Recruiting | Brisbane | Queensland | Australia |
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| Bundaberg Base Hospital | Recruiting | Bundaberg | Queensland | Australia |
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| Cairns Hospital | Recruiting | Cairns | Queensland | 4870 | Australia |
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| Townsville Hospital | Recruiting | Douglas | Queensland | 4814 | Australia |
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| Ipswich Hospital | Recruiting | Ipswich | Queensland | 4305 | Australia |
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| Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | Australia |
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| Sunshine Hospital (Western Health) | Recruiting | St Albans | Victoria | Australia |
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| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
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| Royal Adelaide Hospital | Recruiting | Adelaide | Australia |
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| Monash Medical Centre | Recruiting | Clayton | Australia |
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| Dunedin Hospital | Recruiting | Dunedin | New Zealand |
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| Auckland City Hospital (Auckland DHB) | Recruiting | Grafton | New Zealand |
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| North Shore Hospital (Waitemata DHB) | Recruiting | Takapuna | New Zealand |
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| Tauranga Hospital | Recruiting | Tauranga | New Zealand |
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| Whangarei Hospital | Recruiting | Whangarei | New Zealand |
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| ID | Term |
|---|---|
| D002115 | Calciphylaxis |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010837 | Vitamin K 1 |
| C110422 | magnesium citrate |
| C017717 | sodium thiosulfate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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