Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000881336
Ethics application status
Approved
Date submitted
15/05/2017
Date registered
16/06/2017
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of 3 different phosphate binders on the formation of calciprotein particles in participants receiving haemodialysis treatment
Scientific title
Sevelamer vs Calcium to Reduce Fetuin A calciprotein particles in dialysis (SCaRF) study
Secondary ID [1] 291942 0
None
Universal Trial Number (UTN)
Trial acronym
SCaRF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 303282 0
Condition category
Condition code
Renal and Urogenital 302712 302712 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Calcium carbonate (oral (600mg tablets), up to 3 tablets three times a day) treatment for 12 weeks followed by randomisation to either :
Calcium Carbonate, oral (800 mg tablets), up to 3 tablets three times a day
Sevelamer Hydrochloride, oral (800 mg tablets), up to 3 tablets three times a day
Sevelamer Carbonate, oral, up to 3 tablets three times a day
for a period of 24 weeks.
Starting dose when changing from calcium carbonate to either Sevelamer carbonate or Sevelamer hydrochloride is based on the number of tablets taken, 1 tablet of calcium carbonate is considered to be equivalent to 1 tablet of Sevelamer carbonate/hydrochloride in terms of binding phosphate in the gastrointestinal tract. Participants will commence the new medication taking the same number of tablets daily as they were on previously. Dosing is dependent participant's serum phosphate level and is targeted to a serum phosphate <2.0 mmol/L. Phosphate is monitored every 4 weeks in line with standard of care, study drug dose remains unchanged unless there is indication of hypo or hyper phophataemia. If serum phosphate is <0.8 mmol/L decrease dose by 1 tablet per day. Participant is withdrawn if serum phosphate is <0.8 m mol/L and not on phosphate binder medication. If serum phosphate is <0.6 mmol/L then all phosphate binders should cease and level should be checked in 3 days. If serum phosphate is above 2.6 mmol/L on maximum dose of phosphate binder (Calcium carbonate > 5.4 g/day (i.e. 9 X 600 mg tablets); Sevelamer HCL > 7.2 g/day (i.e. 9 X 800 mg tablets); Sevelamer carbonate >7.2 g/day (i.e. 9 X 800 mg tablets )then participant should be withdrawn from the study.
Compliance will be monitored by package returns.
Intervention code [1] 298065 0
Treatment: Drugs
Comparator / control treatment
Comparisons will be made with all three groups
Control group
Active

Outcomes
Primary outcome [1] 302109 0
Levels of fetuin A - calciprotein particles in serum obtained from participants in each group
Timepoint [1] 302109 0
36 weeks
Secondary outcome [1] 334812 0
Changes in vascular stiffness as measured by central pulse wave velocity.
Timepoint [1] 334812 0
36 weeks

Eligibility
Key inclusion criteria
Patients receiving haemodialysis treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled plasma phosphate (>2.6 mmol/L)
Cinacalcet use
Patients likely to have a parathyroidectomy
Allergy or intolerance to sevelamer or calcium carbonate
Lower limb amputation
History of calciphylaxis

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)
Computer based randomisation. Allocation by central computer is concealed to person making allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8022 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 16004 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 296454 0
Commercial sector/Industry
Name [1] 296454 0
Sanofi Aventis
Country [1] 296454 0
Singapore
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street, Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 295410 0
None
Name [1] 295410 0
Address [1] 295410 0
Country [1] 295410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297679 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 297679 0
Ethics committee country [1] 297679 0
Australia
Date submitted for ethics approval [1] 297679 0
Approval date [1] 297679 0
17/09/2015
Ethics approval number [1] 297679 0
HREC/15/MH/261

Summary
Brief summary
The purpose of the study is to look at the effect of 3 registered phosphate binder on serum calci-protein particle formation. It is hypothesised that formation of these particles may link inflammation with vascular stiffening and calcification. In turn the class of phosphate binder used my impact the quantity of these particles produced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74794 0
Prof Stephen Holt
Address 74794 0
Department of Nephrology, Royal Melbourne Hospital, Grattan Street, Parkville, Vic 3050
Country 74794 0
Australia
Phone 74794 0
+61393427000
Fax 74794 0
Email 74794 0
steve.holt@mh.org.au
Contact person for public queries
Name 74795 0
Ms Maria Farrell
Address 74795 0
Department of Nephrology, Royal Melbourne Hospital, Grattan Street, Parkville, Vic 3050
Country 74795 0
Australia
Phone 74795 0
+61393427077
Fax 74795 0
Email 74795 0
maria.farrell@mh.org.au
Contact person for scientific queries
Name 74796 0
Prof Stephen Holt
Address 74796 0
Department of Nephrology, Royal Melbourne Hospital, Grattan Street, Parkville, Vic 3050
Country 74796 0
Australia
Phone 74796 0
+61393427000
Fax 74796 0
Email 74796 0
steve.holt@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Sevelamer on Calciprotein Particles in Hemodialysis Patients: The Sevelamer Versus Calcium to Reduce Fetuin-A-Containing Calciprotein Particles in Dialysis (SCaRF) Randomized Controlled Trial.2020https://dx.doi.org/10.1016/j.ekir.2020.06.014
N.B. These documents automatically identified may not have been verified by the study sponsor.