RecruitingPhase 3NCT05018221

Better Evidence and Translation for Calciphylaxis


Sponsor

University of Sydney

Enrollment

350 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called High Flux Dialyser, a drug called Magnesium citrate, and others for people with calciphylaxis. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin K1

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

DRUGMagnesium 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.

DRUGSodium Thiosulfate

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

DEVICEHigh Flux Dialyser

Hemodialysis using a high flux dialyser.

DEVICEMedium Cut-off Dialyser

Hemodialysis using a medium cut-off dialyser.

DRUGPlacebo injection (normal saline)

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

DRUGPlacebo capsule (Vitamin K1)

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

DRUGPlacebo 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

View Full Details on ClinicalTrials.gov

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NCT05018221


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