Better Evidence and Translation for Calciphylaxis

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.

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.

Sponsors & Collaborators

• Australasian Kidney Trials Network

  collaborator NETWORK

• Northern Care Alliance NHS Foundation Trust

  collaborator OTHER

• Waitemata District Health Board

  collaborator OTHER_GOV

• Vantive Health LLC

  collaborator INDUSTRY

• Berry Consultants

  collaborator OTHER

• University of Sydney

  lead OTHER

Principal Investigators

• Meg Jardine · University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-26

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Australia
• New Zealand

Study Locations