NCT05018221 Better Evidence and Translation for Calciphylaxis
| NCT ID | NCT05018221 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Sydney |
| Condition | Calciphylaxis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2021-08-26 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2021-08-26 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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 2. Have a new calciphylaxis ulcer present for less than 10 weeks 3. Age ≥ 18 years 4. Eligible for randomisation in at least one recruiting domain 5. The participant and treating physician are willing and able to perform trial procedures Exclusion Criteria: Nil
Contact & Investigator
Meg Jardine
STUDY CHAIR
University of Sydney
Frequently Asked Questions
Who can join the NCT05018221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Calciphylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05018221 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT05018221 currently recruiting?
Yes, NCT05018221 is actively recruiting participants. Contact the research team at sibyl.masterman@sydney.edu.au for enrollment information.
Where is the NCT05018221 trial being conducted?
This trial is being conducted at Concord, Australia, Kogarah, Australia, Liverpool, Australia, New Lambton Heights, Australia and 11 additional locations.
Who is sponsoring the NCT05018221 clinical trial?
NCT05018221 is sponsored by University of Sydney. The principal investigator is Meg Jardine at University of Sydney. The trial plans to enroll 350 participants.