Better Evidence and Translation for Calciphylaxis
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• The participant and treating physician are willing and able to perform trial procedures
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Sunshine Coast Hospital and Health Service
RECRUITING
Birtinya
Princess Alexandra Hospital
RECRUITING
Brisbane
Bundaberg Base Hospital
RECRUITING
Bundaberg
Cairns Hospital
RECRUITING
Cairns
Monash Medical Centre
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Townsville Hospital
RECRUITING
Douglas
Ipswich Hospital
RECRUITING
Ipswich
St George Hospital
RECRUITING
Kogarah
Liverpool Hospital
RECRUITING
Liverpool
Royal Melbourne Hospital
RECRUITING
Melbourne
John Hunter Hospital
RECRUITING
New Lambton Heights
Royal Perth Hospital
RECRUITING
Perth
Sunshine Hospital (Western Health)
RECRUITING
St Albans
Westmead Hospital
RECRUITING
Westmead
New Zealand
Dunedin Hospital
RECRUITING
Dunedin
Auckland City Hospital (Auckland DHB)
RECRUITING
Grafton
North Shore Hospital (Waitemata DHB)
RECRUITING
Takapuna
Tauranga Hospital
RECRUITING
Tauranga
Whangarei Hospital
RECRUITING
Whangarei
Contact Information
Primary
Sibyl Masterman
sibyl.masterman@sydney.edu.au
8036 5272
Backup
Meg Jardine
meg.jardine@sydney.edu.au
9562 5000
Time Frame
Start Date: 2021-08-26
Estimated Completion Date: 2029-12
Participants
Target number of participants: 350
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Northern Care Alliance NHS Foundation Trust, Australasian Kidney Trials Network, Waitemata District Health Board, Berry Consultants, Vantive Health LLC
Leads: University of Sydney