Health TrialsbyHealthPanel

Better Evidence and Translation for Calciphylaxis

ConditionCalciphylaxis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

About this trial

This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Vitamin K1

    Drug

    Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.

  • 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.

  • Sodium Thiosulfate

    Drug

    Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

  • High Flux Dialyser

    Device

    Hemodialysis using a high flux dialyser.

  • Medium Cut-off Dialyser

    Device

    Hemodialysis using a medium cut-off dialyser.

  • Placebo injection (normal saline)

    Drug

    Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

  • Placebo capsule (Vitamin K1)

    Drug

    Placebo to be administered 3 times per week following the subject's hemodialysis session.

  • 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.

Treatment groups

350 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Placebo (Double-Blind Period)Placebo comparator 3 interventions
Group B: Vitamin K1 (Double-Blind Period)Experimental treatment 3 interventions
Group C: Magnesium Citrate (Double-Blind Period)Experimental treatment 3 interventions
Group D: Sodium Thiosulfate (Double-Blind Period)Experimental treatment 3 interventions
Group E: High Flux HemodialysisActive comparator 1 intervention
Group F: Medium Cut-off HemodialysisExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Week 12

Secondary outcomes

1

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

Time frame
Week 26
2

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

Time frame
Week 4
3

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

Time frame
Week 12
4

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

Time frame
Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sydney

Lead sponsor

Australasian Kidney Trials Network

Collaborator

Northern Care Alliance NHS Foundation Trust

Collaborator

Waitemata District Health Board

Collaborator

Vantive Health LLC

Collaborator

Berry Consultants

Collaborator

Source ClinicalTrials.gov
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