Evaluating treatments for calciphylaxis in kidney failure patients
Better Evidence and Translation for Calciphylaxis
This study is testing different treatments for adults with kidney failure who have just been diagnosed with calciphylaxis to see which ones work best.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sydney Academic / other |
| Locations | 21 sites (Concord, New South Wales and 20 other locations) |
| Trial ID | NCT05018221 on ClinicalTrials.gov |
What this trial studies
This global platform study, known as BEAT-Calci, aims to evaluate various interventions for adult patients with kidney failure and newly diagnosed calciphylaxis. It is a randomized, adaptive, multi-center trial that will assess the effectiveness of pharmacotherapy and dialysis technologies. The study will utilize a Bayesian adaptive sample size approach and will continue to recruit participants until specific superiority or futility criteria are met. The primary endpoint is the BEAT-Calci Wound Assessment Scale, which measures disease outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving dialysis and have a new calciphylaxis ulcer present for less than 10 weeks.
Not a fit: Patients who do not have kidney failure or calciphylaxis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients suffering from calciphylaxis, potentially improving their health outcomes.
How similar studies have performed: While calciphylaxis is a rare condition, previous studies on similar interventions in kidney disease have shown promising results, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Concord, New South Wales and 20 other locations
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (Recruiting)
- St George Hospital — Kogarah, New South Wales, Australia (Recruiting)
- Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
- Sunshine Coast Hospital and Health Service — Birtinya, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
- Bundaberg Base Hospital — Bundaberg, Queensland, Australia (Recruiting)
- Cairns Hospital — Cairns, Queensland, Australia (Recruiting)
- Townsville Hospital — Douglas, Queensland, Australia (Recruiting)
- Ipswich Hospital — Ipswich, Queensland, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Sunshine Hospital (Western Health) — St Albans, Victoria, Australia (Recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, Australia (Recruiting)
- Monash Medical Centre — Clayton, Australia (Recruiting)
- Dunedin Hospital — Dunedin, New Zealand (Recruiting)
- Auckland City Hospital (Auckland DHB) — Grafton, New Zealand (Recruiting)
- North Shore Hospital (Waitemata DHB) — Takapuna, New Zealand (Recruiting)
- Tauranga Hospital — Tauranga, New Zealand (Recruiting)
- Whangarei Hospital — Whangarei, New Zealand (Recruiting)
Study contacts
- Study coordinator: Sibyl Masterman
- Email: sibyl.masterman@sydney.edu.au
- Phone: 8036 5272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.