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Better Evidence and Translation for Calciphylaxis
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-08-26
Primary completion: 2029-12-01
Study completion finish: 2029-12-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05018221
Intervention or treatment
DRUG: Vitamin K1
DRUG: Magnesium citrate
DRUG: Sodium Thiosulfate
DEVICE: High Flux Dialyser
DEVICE: Medium Cut-off Dialyser
DRUG: Placebo injection (normal saline)
DRUG: Placebo capsule (Vitamin K1)
DRUG: Placebo tablet (Magnesium citrate)
Conditions
- • Calciphylaxis
Find a site
Closest Location:
Princess Alexandra Hospital
Research sites nearby
Select from list below to view details:
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Monash Medical Centre
Clayton, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
PLACEBO_COMPARATOR: Placebo (Double-Blind Period)
| DRUG: Placebo injection (normal saline)
|
EXPERIMENTAL: Vitamin K1 (Double-Blind Period)
| DRUG: Vitamin K1
|
EXPERIMENTAL: Magnesium Citrate (Double-Blind Period)
| DRUG: Magnesium citrate
|
EXPERIMENTAL: Sodium Thiosulfate (Double-Blind Period)
| DRUG: Sodium Thiosulfate
|
ACTIVE_COMPARATOR: High Flux Hemodialysis
| DEVICE: High Flux Dialyser
|
EXPERIMENTAL: Medium Cut-off Hemodialysis
| DEVICE: Medium Cut-off Dialyser
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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: 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 outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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: 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 26 |
| Distribution of each of the individual components of the BCWAS, assessed at Weeks 4 | To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Weeks 4 Scale described as: 1. Complete epithelialisation of the sentinel ulcer 2. \>50% reduction in sentinel ulcer surface area 3. 20-50% reduction in sentinel ulcer surface area 4. 0-20% reduction in sentinel ulcer surface area 5. Any increase in sentinel ulcer surface area 6. Development of new ulcers 7. Amputation due to an ulcer 8. All-cause death | Week 4 |
| Distribution of each of the individual components of the BCWAS, assessed at Week 12 | To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Week 12 Scale described as: 1. Complete epithelialisation of the sentinel ulcer 2. \>50% reduction in sentinel ulcer surface area 3. 20-50% reduction in sentinel ulcer surface area 4. 0-20% reduction in sentinel ulcer surface area 5. Any increase in sentinel ulcer surface area 6. Development of new ulcers 7. Amputation due to an ulcer 8. All-cause death | Week 12 |
| Distribution of each of the individual components of the BCWAS, assessed at Week 26 | To determine whether addition of the intervention changes the distribution of each of the individual components of the BEAT-Calci Wound Assessment Scale, assessed at Week 26. Scale described as: 1. Complete epithelialisation of the sentinel ulcer 2. \>50% reduction in sentinel ulcer surface area 3. 20-50% reduction in sentinel ulcer surface area 4. 0-20% reduction in sentinel ulcer surface area 5. Any increase in sentinel ulcer surface area 6. Development of new ulcers 7. Amputation due to an ulcer 8. All-cause death | 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 |
Frequently Asked Questions
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