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RECRUITING
NCT05018221
PHASE3

Better Evidence and Translation for Calciphylaxis

Sponsor: University of Sydney

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2021-08-26

Completion Date

2029-12

Last Updated

2025-08-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Vitamin K1

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

DRUG

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.

DRUG

Sodium Thiosulfate

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

DEVICE

High Flux Dialyser

Hemodialysis using a high flux dialyser.

DEVICE

Medium Cut-off Dialyser

Hemodialysis using a medium cut-off dialyser.

DRUG

Placebo injection (normal saline)

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

DRUG

Placebo capsule (Vitamin K1)

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

DRUG

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.

Locations (21)

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

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Bundaberg Base Hospital

Bundaberg, Queensland, Australia

Cairns Hospital

Cairns, Queensland, Australia

Townsville Hospital

Douglas, Queensland, Australia

Ipswich Hospital

Ipswich, Queensland, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Sunshine Hospital (Western Health)

St Albans, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Royal Adelaide Hospital

Adelaide, Australia

Monash Medical Centre

Clayton, Australia

Dunedin Hospital

Dunedin, New Zealand

Auckland City Hospital (Auckland DHB)

Grafton, New Zealand

North Shore Hospital (Waitemata DHB)

Takapuna, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Whangarei Hospital

Whangarei, New Zealand