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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05018221




Registration number
NCT05018221
Ethics application status
Date submitted
9/08/2021
Date registered
24/08/2021

Titles & IDs
Public title
Better Evidence and Translation for Calciphylaxis
Scientific title
Better Evidence and Translation for Calciphylaxis
Secondary ID [1] 0 0
BEAT-Calci
Universal Trial Number (UTN)
Trial acronym
BEAT-Calci
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calciphylaxis 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vitamin K1
Treatment: Drugs - Magnesium citrate
Treatment: Drugs - Sodium Thiosulfate
Treatment: Devices - High Flux Dialyser
Treatment: Devices - Medium Cut-off Dialyser
Treatment: Drugs - Placebo injection (normal saline)
Treatment: Drugs - Placebo capsule (Vitamin K1)
Treatment: Drugs - Placebo tablet (Magnesium citrate)

Placebo comparator: Placebo (Double-Blind Period) - Placebo Vitamin K1 Placebo Magnesium Citrate Placebo Sodium Thiosulphate

Experimental: Vitamin K1 (Double-Blind Period) - Dose: 10mg Vitamin K1 capsules, administered 3 times per week following the subject's hemodialysis session.

* Placebo Magnesium Citrate
* Placebo Sodium Thiosulphate

Experimental: Magnesium Citrate (Double-Blind Period) - Dose: 150mg Magnesium Citrate tablets, administered 3 times per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session.

* Placebo Vitamin K1
* Placebo Sodium Thiosulphate

Experimental: Sodium Thiosulfate (Double-Blind Period) - Dose: 25g Sodium Thiosulfate injection, administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

* Placebo Vitamin K1
* Placebo Magnesium Citrate

Active comparator: High Flux Hemodialysis - Hemodialysis using a high flux dialyser

Experimental: Medium Cut-off Hemodialysis - Hemodialysis using a medium cut-off dialyser


Treatment: Drugs: Vitamin K1
Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.

Treatment: Drugs: 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.

Treatment: Drugs: Sodium Thiosulfate
Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

Treatment: Devices: High Flux Dialyser
Hemodialysis using a high flux dialyser.

Treatment: Devices: Medium Cut-off Dialyser
Hemodialysis using a medium cut-off dialyser.

Treatment: Drugs: Placebo injection (normal saline)
Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.

Treatment: Drugs: Placebo capsule (Vitamin K1)
Placebo to be administered 3 times per week following the subject's hemodialysis session.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
BEAT-Calci Wound Assessment Scale - Baseline to Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Distribution of each of the individual components of the BCWAS, assessed at Weeks 4
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Distribution of each of the individual components of the BCWAS, assessed at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Distribution of each of the individual components of the BCWAS, assessed at Week 26
Timepoint [4] 0 0
Week 26
Secondary outcome [5] 0 0
Bates-Jensen Wound Assessment Tool - from Baseline to Week 4
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
Bates-Jensen Wound Assessment Tool - from Baseline to Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Bates-Jensen Wound Assessment Tool - from Baseline to Week 26
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Sentinel ulcer surface area - from Baseline, assessed at Week 4
Timepoint [8] 0 0
Week 4
Secondary outcome [9] 0 0
Sentinel ulcer surface area - from Baseline, assessed at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Sentinel ulcer surface area - from Baseline, assessed at Week 26
Timepoint [10] 0 0
Week 26
Secondary outcome [11] 0 0
All ulcers total surface area - from Baseline, assessed at Week 4
Timepoint [11] 0 0
Week 4
Secondary outcome [12] 0 0
All ulcers total surface area - from Baseline, assessed at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
All ulcers total surface area - from Baseline, assessed at Week 26
Timepoint [13] 0 0
Week 26
Secondary outcome [14] 0 0
Change over time of self-reported pain
Timepoint [14] 0 0
Week 26
Secondary outcome [15] 0 0
Self-reported pain at week 12
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Change over time of analgesic use
Timepoint [16] 0 0
Week 26
Secondary outcome [17] 0 0
Analgesic use week 12
Timepoint [17] 0 0
Week 12
Secondary outcome [18] 0 0
Composite self-reported pain and analgesic use over time
Timepoint [18] 0 0
Week 26
Secondary outcome [19] 0 0
Composite self-reported pain and analgesic use at week 12
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Change in self-reported quality of life from Baseline to Week 4
Timepoint [20] 0 0
Week 4
Secondary outcome [21] 0 0
Change in self-reported quality of life from Baseline to Week 12
Timepoint [21] 0 0
Week 12
Secondary outcome [22] 0 0
Change in self-reported quality of life from Baseline to Week 26
Timepoint [22] 0 0
Week 26
Secondary outcome [23] 0 0
Time to first calciphylaxis-attributable infection from Baseline to Week 26
Timepoint [23] 0 0
Week 26
Secondary outcome [24] 0 0
All-cause hospitalisation days
Timepoint [24] 0 0
Weeks 0-26
Secondary outcome [25] 0 0
Mortality
Timepoint [25] 0 0
Up to 5 years
Secondary outcome [26] 0 0
Kidney Transplantation
Timepoint [26] 0 0
Up to 5 years
Secondary outcome [27] 0 0
Calciphylaxis recurrence
Timepoint [27] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Bundaberg Base Hospital - Bundaberg
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
Sunshine Hospital (Western Health) - St Albans
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Birtinya
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Bundaberg
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- St Albans
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Dunedin
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Takapuna
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
New Zealand
State/province [5] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Kidney Trials Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Care Alliance NHS Foundation Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Waitemata District Health Board
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Meg Jardine
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sibyl Masterman
Address 0 0
Country 0 0
Phone 0 0
8036 5272
Fax 0 0
Email 0 0
sibyl.masterman@sydney.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.

Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.

Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
To be confirmed
Available to whom?
* No data should be released that would compromise the trial, unless specifically for safety reasons.
* There must be a strong scientific or other legitimate rationale for the data to be used for the requested purpose.
* Investigators should have a period of exclusivity in which to pursue their aims with the data, before key trial data are made available to other researchers.
* Adequate resources must be available in order to comply with the request, and the scientific aims of the study must justify the use of such resources.
* Data release complies with the relevant regulations from all relevant countries.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05018221