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Better Evidence and Translation for Calciphylaxis

PHASE3RECRUITING

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

  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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study 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

  • Condition: Calciphylaxis

  • DRUG: Vitamin K1 and other drugs

  • Concord, New South Wales, Australia and more

  • Sponsor: University of Sydney

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Concord Repatriation General Hospital

Select from list below to view details:

  • Concord Repatriation General Hospital

    Concord, New South Wales, Australia

  • St George Hospital

    Kogarah, New South Wales, Australia

  • Liverpool Hospital

    Liverpool, New South Wales, Australia

  • John Hunter Hospital

    New Lambton Heights, New South Wales, Australia

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Who is running the clinical trial?

UoS

University of Sydney

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/ArmIntervention/Treatment
PLACEBO_COMPARATOR: Placebo (Double-Blind Period)
  • Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate
Drug: Placebo injection (normal saline), Drug: Placebo capsule (Vitamin K1), Drug: Placebo tablet (Magnesium citrate)
    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
    Drug: Vitamin K1, Drug: Placebo injection (normal saline), Drug: Placebo tablet (Magnesium citrate)
      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
      Drug: Magnesium citrate, Drug: Placebo injection (normal saline), Drug: Placebo capsule (Vitamin K1)
        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
        Drug: Sodium Thiosulfate, Drug: Placebo capsule (Vitamin K1), Drug: Placebo tablet (Magnesium citrate)
          ACTIVE_COMPARATOR: High Flux Hemodialysis
          • Hemodialysis using a high flux dialyser
          Device: High Flux Dialyser
            EXPERIMENTAL: Medium Cut-off Hemodialysis
            • Hemodialysis using a medium cut-off dialyser
            Device: Medium Cut-off Dialyser

              What is the study measuring?

              Primary Outcome

              MeasureDescriptionTime Frame
              BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12To 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 deathWeek 12

              Secondary Outcome

              MeasureDescriptionTime Frame
              BEAT-Calci Wound Assessment Scale - Baseline to Week 26To 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 deathWeek 26
              Distribution of each of the individual components of the BCWAS, assessed at Weeks 4To 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 deathWeek 4
              Distribution of each of the individual components of the BCWAS, assessed at Week 12To 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 deathWeek 12
              Distribution of each of the individual components of the BCWAS, assessed at Week 26To 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 deathWeek 26
              Bates-Jensen Wound Assessment Tool - from Baseline to Week 4To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 4 using the Bates-Jensen Wound Assessment ToolWeek 4
              Bates-Jensen Wound Assessment Tool - from Baseline to Week 12To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 12, using the Bates-Jensen Wound Assessment ToolWeek 12
              Bates-Jensen Wound Assessment Tool - from Baseline to Week 26To determine whether addition of the intervention changes the severity of sentinel ulcer from Baseline, assessed at Week 26, using the Bates-Jensen Wound Assessment ToolWeek 26
              Sentinel ulcer surface area - from Baseline, assessed at Week 4To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 4Week 4
              Sentinel ulcer surface area - from Baseline, assessed at Week 12To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 12Week 12
              Sentinel ulcer surface area - from Baseline, assessed at Week 26To determine whether addition of the intervention changes the surface area of sentinel ulcer from Baseline, assessed at Week 26Week 26
              All ulcers total surface area - from Baseline, assessed at Week 4To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 4Week 4
              All ulcers total surface area - from Baseline, assessed at Week 12To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 12Week 12
              All ulcers total surface area - from Baseline, assessed at Week 26To determine whether addition of the intervention changes the total surface area of all ulcers (not only the sentinel ulcer) from Baseline, assessed at Week 26Week 26
              Change over time of self-reported painTo determine whether addition of the intervention changes self-reported pain over time, assessed using the 0-to-10 Numerical Rating ScaleWeek 26
              Self-reported pain at week 12To determine whether addition of the intervention changes self-reported pain use at week 12 assessed using the 0-to-10 Numerical Rating ScaleWeek 12
              Change over time of analgesic useTo determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 26Week 26
              Analgesic use week 12To determine whether addition of the intervention changes analgesic use over time, as measured by cumulative weighted analgesia dose from baseline to week 12Week 12
              Composite self-reported pain and analgesic use over timeTo 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 timeWeek 26
              Composite self-reported pain and analgesic use at week 12To 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 12Week 12
              Change in self-reported quality of life from Baseline to Week 4To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 4, using the EuroQoL EQ-5D-5L instrumentWeek 4
              Change in self-reported quality of life from Baseline to Week 12To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 12, using the EuroQoL EQ-5D-5L instrumentWeek 12
              Change in self-reported quality of life from Baseline to Week 26To determine whether addition of the intervention changes self-reported quality of life from Baseline, assessed at Week 26 using the EuroQoL EQ-5D-5L instrumentWeek 26
              Time to first calciphylaxis-attributable infection from Baseline to Week 26Time in days to first calciphylaxis-attributable infection within 26 weeks post-randomisationWeek 26
              All-cause hospitalisation daysCount of all cause hospitalisation days (excluding day admissions for dialysis treatment within 26 weeks post-randomisationWeeks 0-26
              MortalityIncidence of mortality, as derived from hospital reports, within 5-years post-randomisationUp to 5 years
              Kidney TransplantationIncidence of kidney transplantation, as derived from hospital reports, within 5-years post-randomisationUp to 5 years
              Calciphylaxis recurrenceIncidence of calciphylaxis recurrence as derived from hospital reports, within 5-years post-randomisationUp to 5 years
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              References

              Clinical Trials Gov: Better Evidence and Translation for Calciphylaxis

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