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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05018221
Registration number
NCT05018221
Ethics application status
Date submitted
9/08/2021
Date registered
24/08/2021
Date last updated
5/12/2023
Titles & IDs
Public title
Better Evidence and Translation for Calciphylaxis
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Scientific title
Better Evidence and Translation for Calciphylaxis
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Secondary ID [1]
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BEAT-Calci
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Universal Trial Number (UTN)
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Trial acronym
BEAT-Calci
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Calciphylaxis
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Condition category
Condition code
Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vitamin K1
Treatment: Drugs - Magnesium citrate
Treatment: Drugs - Sodium Thiosulfate
Treatment: Devices - High Flux Dialyser
Treatment: Devices - Medium Cut-off Dialyser
Treatment: Drugs - Placebo injection (normal saline)
Treatment: Drugs - Placebo capsule (Vitamin K1)
Treatment: Drugs - Placebo tablet (Magnesium citrate)
Placebo Comparator: Placebo (Double-Blind Period) - Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate
Experimental: Vitamin K1 (Double-Blind Period) - Dose: 10mg Vitamin K1 capsules, administered 3 times per week following the subject's hemodialysis session.
Placebo Magnesium Citrate
Placebo Sodium Thiosulphate
Experimental: Magnesium Citrate (Double-Blind Period) - 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
Experimental: Sodium Thiosulfate (Double-Blind Period) - 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
Active Comparator: High Flux Hemodialysis - Hemodialysis using a high flux dialyser
Experimental: Medium Cut-off Hemodialysis - Hemodialysis using a medium cut-off dialyser
Treatment: Drugs: Vitamin K1
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
Treatment: Drugs: Magnesium citrate
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.
Treatment: Drugs: Sodium Thiosulfate
Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Treatment: Devices: High Flux Dialyser
Hemodialysis using a high flux dialyser.
Treatment: Devices: Medium Cut-off Dialyser
Hemodialysis using a medium cut-off dialyser.
Treatment: Drugs: Placebo injection (normal saline)
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Treatment: Drugs: Placebo capsule (Vitamin K1)
Placebo to be administered 3 times per week following the subject's hemodialysis session.
Treatment: Drugs: Placebo tablet (Magnesium citrate)
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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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12
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Assessment method [1]
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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
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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BEAT-Calci Wound Assessment Scale - Baseline to Week 26
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Assessment method [1]
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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
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Timepoint [1]
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Week 26
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Secondary outcome [2]
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Distribution of each of the individual components of the BCWAS, assessed at Weeks 4
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Assessment method [2]
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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
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Timepoint [2]
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Week 4
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Secondary outcome [3]
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Distribution of each of the individual components of the BCWAS, assessed at Week 12
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Assessment method [3]
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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
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Distribution of each of the individual components of the BCWAS, assessed at Week 26
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Assessment method [4]
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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
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Timepoint [4]
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Week 26
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Secondary outcome [5]
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Bates-Jensen Wound Assessment Tool - from Baseline to Week 4
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Assessment method [5]
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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
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Timepoint [5]
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Week 4
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Secondary outcome [6]
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Bates-Jensen Wound Assessment Tool - from Baseline to Week 12
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Assessment method [6]
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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
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Bates-Jensen Wound Assessment Tool - from Baseline to Week 26
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Assessment method [7]
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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
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Timepoint [7]
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Week 26
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Secondary outcome [8]
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Sentinel ulcer surface area - from Baseline, assessed at Week 4
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Assessment method [8]
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To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 4
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Timepoint [8]
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Week 4
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Secondary outcome [9]
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Sentinel ulcer surface area - from Baseline, assessed at Week 12
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Assessment method [9]
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To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 12
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Sentinel ulcer surface area - from Baseline, assessed at Week 26
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Assessment method [10]
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To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 26
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Timepoint [10]
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Week 26
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Secondary outcome [11]
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All ulcers total surface area - from Baseline, assessed at Week 4
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Assessment method [11]
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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
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Timepoint [11]
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Week 4
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Secondary outcome [12]
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All ulcers total surface area - from Baseline, assessed at Week 12
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Assessment method [12]
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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
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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All ulcers total surface area - from Baseline, assessed at Week 26
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Assessment method [13]
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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
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Timepoint [13]
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Week 26
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Secondary outcome [14]
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Change over time of self-reported pain
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Assessment method [14]
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To determine whether addition of the intervention changes self-reported pain over time, assessed using the 0-to-10 Numerical Rating Scale
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Timepoint [14]
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Week 26
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Secondary outcome [15]
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Self-reported pain at week 12
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Assessment method [15]
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To determine whether addition of the intervention changes self-reported pain use at week 12 assessed using the 0-to-10 Numerical Rating Scale
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Timepoint [15]
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Week 12
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Secondary outcome [16]
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Change over time of analgesic use
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Assessment method [16]
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To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 26
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Timepoint [16]
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Week 26
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Secondary outcome [17]
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Analgesic use week 12
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Assessment method [17]
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To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 12
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Timepoint [17]
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Week 12
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Secondary outcome [18]
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Composite self-reported pain and analgesic use over time
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Assessment method [18]
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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
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Timepoint [18]
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Week 26
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Secondary outcome [19]
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Composite self-reported pain and analgesic use at week 12
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Assessment method [19]
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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
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Timepoint [19]
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Week 12
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Secondary outcome [20]
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Change in self-reported quality of life from Baseline to Week 4
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Assessment method [20]
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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
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Timepoint [20]
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Week 4
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Secondary outcome [21]
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Change in self-reported quality of life from Baseline to Week 12
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Assessment method [21]
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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
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Timepoint [21]
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Week 12
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Secondary outcome [22]
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Change in self-reported quality of life from Baseline to Week 26
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Assessment method [22]
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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
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Timepoint [22]
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Week 26
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Secondary outcome [23]
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Time to first calciphylaxis-attributable infection from Baseline to Week 26
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Assessment method [23]
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Time in days to first calciphylaxis-attributable infection within 26 weeks post-randomisation
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Timepoint [23]
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Week 26
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Secondary outcome [24]
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All-cause hospitalisation days
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Assessment method [24]
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Count of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisation
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Timepoint [24]
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Weeks 0-26
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Secondary outcome [25]
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Mortality
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Assessment method [25]
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Incidence of mortality, as derived from hospital reports, within 5-years post-randomisation
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Timepoint [25]
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Up to 5 years
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Secondary outcome [26]
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Kidney Transplantation
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Assessment method [26]
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Incidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisation
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Timepoint [26]
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Up to 5 years
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Secondary outcome [27]
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Calciphylaxis recurrence
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Assessment method [27]
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Incidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisation
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Timepoint [27]
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Up to 5 years
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Eligibility
Key inclusion criteria
1. 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
2. Have a new calciphylaxis ulcer present for less than 10 weeks
3. Age = 18 years
4. Eligible for randomisation in at least one recruiting domain
5. The participant and treating physician are willing and able to perform trial
procedures
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Nil
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
350
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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St George Hospital - Kogarah
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Recruitment hospital [3]
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Sunshine Coast Hospital and Health Service - Birtinya
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Recruitment hospital [4]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [5]
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Bundaberg Base Hospital - Bundaberg
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Recruitment hospital [6]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [7]
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Sunshine Hospital (Western Health) - St Albans
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Kogarah
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Recruitment postcode(s) [3]
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- Birtinya
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Recruitment postcode(s) [4]
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- Brisbane
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Recruitment postcode(s) [5]
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- Bundaberg
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Recruitment postcode(s) [6]
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- Melbourne
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Recruitment postcode(s) [7]
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- St Albans
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Recruitment postcode(s) [8]
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- Adelaide
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Recruitment postcode(s) [9]
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- Clayton
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Dunedin
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Country [2]
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New Zealand
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State/province [2]
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Grafton
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Country [3]
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New Zealand
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State/province [3]
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Takapuna
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Country [4]
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New Zealand
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State/province [4]
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Tauranga
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Kidney Trials Network
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Northern Care Alliance NHS Foundation Trust
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Waitemata District Health Board
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05018221
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Meg Jardine
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sibyl Masterman
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Address
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Country
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Phone
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8036 5272
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05018221
Download to PDF