Clinical trial
Better Evidence and Translation for Calciphylaxis
Name
BEAT-Calci
Description
This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.
Trial arms
Trial start
2021-08-26
Estimated PCD
2029-12-01
Trial end
2029-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Vitamin K1
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
Arms:
Vitamin K1 (Double-Blind Period)
Other names:
Phytonadione
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.
Arms:
Magnesium Citrate (Double-Blind Period)
Sodium Thiosulfate
Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Arms:
Sodium Thiosulfate (Double-Blind Period)
Other names:
Intravenous Sodium Thiosulfate Injection
High Flux Dialyser
Hemodialysis using a high flux dialyser.
Arms:
High Flux Hemodialysis
Other names:
High Flux Hemodialysis
Medium Cut-off Dialyser
Hemodialysis using a medium cut-off dialyser.
Arms:
Medium Cut-off Hemodialysis
Other names:
Medium Cut-off Hemodialysis
Placebo injection (normal saline)
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
Arms:
Magnesium Citrate (Double-Blind Period), Placebo (Double-Blind Period), Vitamin K1 (Double-Blind Period)
Other names:
0.9% sodium chloride solution
Placebo capsule (Vitamin K1)
Placebo to be administered 3 times per week following the subject's hemodialysis session.
Arms:
Magnesium Citrate (Double-Blind Period), Placebo (Double-Blind Period), Sodium Thiosulfate (Double-Blind Period)
Other names:
Matching placebo capsule
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.
Arms:
Placebo (Double-Blind Period), Sodium Thiosulfate (Double-Blind Period), Vitamin K1 (Double-Blind Period)
Other names:
Matching placebo tablet
Size
350
Primary endpoint
BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12
Week 12
Eligibility criteria
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
Exclusion Criteria:
Nil
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Adaptive, platform, randomized controlled trial, involving multiple interventions spanning several domains of therapeutic care.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.\n\nWithin 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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}
Updated at
2023-12-05
1 organization
Organization
University of Sydney