About Us

Registry Structure

Registry structure

  1. The registry is to be affiliated with the Australasian Kidney Trials Network (AKTN) and the Australian and New Zealand Society of Nephrology (ANZSN).

  2. The advisory committee is to be constituted from members of the ANZSN. Current members are Grahame Elder, Carmel Hawley, Nigel Toussaint and Eugenie Pedagogos.

  3. Members of the ANZSN may be invited to join the advisory committee of the Calciphylaxis Registry from time to time by a majority vote of current members.

  4. The advisory committee, in discussion with the ANZSN and the AKTN, and with ethical approval, will determine how data collected by the registry should be used.

  5. Access to the registry is to be via a web site; www.calciphylaxis.org.au .

  6. The website will provide information for patients and their families on research and advances in management. The registry will also provide patients and their families information on research programs in which their participation may be valuable.

  7. The website will provide information to physicians and nursing staff, including contact information for direct advice or discussion with one of the advisory committee members.

  8. The website will have a password protected area for information on submission of clinical data and laboratory samples for patients identified with calciphylaxis.

  9. Provision of clinical data and samples will require ethics approval from the site, using a site specific application. It is proposed that a standard ethics application be submitted at most major renal facilities, so that delays would be minimised when a case of calciphylaxis is identified.  

  10. The registry is to pool information and cooperate in research programs with the current German Calciphylaxis Registry and with other national registries that may be developed, providing patient confidentiality, privacy and ethical standards are maintained.

Extent of the registry

Geographical extent: Australia, although no exclusion of non-Australian participants.
 

Medical disciplines: Calciphylaxis is most often diagnosed by renal physicians. However, other specialists in hyperbaric medicine, dermatologists, endocrinologists, orthopaedic surgeons and plastic surgeons who may see people with calciphylaxis or  related condition such as tumoral calcinosis and heterotopic ossification are also invited to participate in development of the Australian Calciphylaxis Registry.

 

Institutions involved: The Registry is located at Westmead Hospital, Sydney, but all departments of nephology in Australian hospitals will be invited to participate.

 
Questions about calciphylaxis to be answered:
i.Incidence and prevalence
ii.Risk factors / associated factors
iii.Predictors of development
iv.Co-morbidities
v.Associated conditions
vi.Clinical management
vii.Outcome

Patient population: Anticipated number of cases reported to the registry per year in Australia would be 50-75. This would ideally be achieving 80% capture of potential cases in Australia per year. Attempts to increase the capture of all cases of calciphylaxis will involve advertising (through symposia, abstract und full text publications) and addressing the non-nephrological community.

Description of patient recruitment: Online access to the registry will be via the website www.calciphylaxis.org.au and will be performed by individual treating physicians (mainly nephrologists), registrars or nursing staff. Notification of patients with calciphylaxis will involve baseline data collection online, then central data processing. Inclusion criteria are any case confirmed or highly suspicious of calciphylaxis (histology not mandatory). Detailed consultation with a member of the advisory committee can occur in cases of doubt. Exclusion criteria include patients unwilling to consent for participation in data collection and an unclear diagnosis of calciphylaxis.

Definition of disease evaluated in the registry: Calciphylaxis (and tumoral calcinosis or heterotopic ossification) will be confirmed by clinical presentation +/- histology +/- imaging.   

Data collection: Retrospective data completion via web page, then prospective data collection with special regard to therapy and outcome by web page, telephone or email questionnaire. Data will include demographics, clinical presentation, diagnostic procedures and biochemical parameters, treatments and outcomes. 
Collection of serum and tissue (from biopsy samples) to be stored in a tissue bank for further analyses. Serum samples will include 3 x 5ml tubes (taken at the time of routine bloods) and will be transported to Westmead Hospital (Department of Renal Medicine). Tissue will only be collected if a biopsy of the calciphylaxis lesion is taken for clinical management of the individual patient. Samples will then be requested for the Registry and transported to Westmead Hospital.

Statistical analysis: Prevalence of risk factors, odds ratio calculations, Kaplan Meier analyses, correlation and regression analyses to determine factors associated with outcome, and intergroup comparisons (survival analyses, renal vs. non-renal forms etc). Analyses will be undertaken when recorded case numbers are sufficient
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