NCT05018221 - Better Evidence and Translation for Calciphylaxis | Biotech Hunter

Enrollment

350

Participants

Timeline

Start Date

August 26, 2021

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions

Calciphylaxis

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.

Trial Locations (21)

2145

RECRUITING

Westmead Hospital, Westmead

2170

RECRUITING

Liverpool Hospital, Liverpool

2305

RECRUITING

John Hunter Hospital, New Lambton Heights

4305

RECRUITING

Ipswich Hospital, Ipswich

4814

RECRUITING

Townsville Hospital, Douglas

4870

RECRUITING

Cairns Hospital, Cairns

6000

RECRUITING

Royal Perth Hospital, Perth

Unknown

RECRUITING

Concord Repatriation General Hospital, Concord

RECRUITING

St George Hospital, Kogarah

RECRUITING

Sunshine Coast Hospital and Health Service, Birtinya

RECRUITING

Princess Alexandra Hospital, Brisbane

RECRUITING

Bundaberg Base Hospital, Bundaberg

RECRUITING

Royal Melbourne Hospital, Melbourne

RECRUITING

Sunshine Hospital (Western Health), St Albans

RECRUITING

Royal Adelaide Hospital, Adelaide

RECRUITING

Monash Medical Centre, Clayton

RECRUITING

Dunedin Hospital, Dunedin

RECRUITING

Auckland City Hospital (Auckland DHB), Grafton

RECRUITING

North Shore Hospital (Waitemata DHB), Takapuna

RECRUITING

Tauranga Hospital, Tauranga

RECRUITING

Whangarei Hospital, Whangarei