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Trial registered on ANZCTR


Registration number
ACTRN12614000548639
Ethics application status
Approved
Date submitted
14/05/2014
Date registered
22/05/2014
Date last updated
12/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of iron deficiency and its treatment on fibroblast growth factor 23 (FGF23) in patients treated with chronic haemodialysis therapy.
Scientific title
Effects of iron deficiency and its treatment on fibroblast growth factor 23 (FGF23) in patients treated with chronic haemodialysis therapy.
Secondary ID [1] 284600 0
None
Universal Trial Number (UTN)
Trial acronym
D-IDENTIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 291901 0
Haemodialysis 291902 0
Iron deficiency 291952 0
Condition category
Condition code
Renal and Urogenital 292247 292247 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200mg Ferric carboxymaltose, intravenous, single dose
Intervention code [1] 289373 0
Treatment: Drugs
Comparator / control treatment
200mg Iron sucrose, intravenous, single dose
Control group
Active

Outcomes
Primary outcome [1] 292113 0
Change from baseline to peak intact FGF23 serum concentration
Timepoint [1] 292113 0
Days 2, 7, 21 and 42 post administration of iron therapy
Secondary outcome [1] 308219 0
Change in serum phosphate concentration
Timepoint [1] 308219 0
Days 2, 7, 21 and 42 post administration of iron therapy
Secondary outcome [2] 308220 0
Change in serum parathyroid hormone concentration
Timepoint [2] 308220 0
Days 2, 7, 21 and 42 post administration of iron therapy
Secondary outcome [3] 308221 0
Change in serum 1,25 dihydroxyvitamin D concentration
Timepoint [3] 308221 0
Days 2, 7, 21 and 42 post administration of iron therapy

Eligibility
Key inclusion criteria
1. Aged 18-90 years
2. Receiving chronic thrice weekly haemodialysis therapy for >3 months
3. Requiring IV iron therapy based on current guidelines
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to give informed consent
2. Active infection
3. Evidence of malignancy
4. Blood transfusion within preceding 4 weeks
5. Initial haemoglobin < 85 g/L
6. Previous hypersensitivity to intravenous iron sucrose or ferric carboxymaltose
7. Recent introduction or change in dose of erythropoietin agents, phosphate binders, vitamin D analogues or cinacalcet (within last 4 weeks)

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)
Haemodialysis patients who meet all the inclusion criteria and none of the exclusion criteria will be approached by a member of the study team. If they are interested in participating in the study the principal or associate investigator will discuss the study with the patient, answer any questions and obtain written informed consent.
Allocation concealment is by sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Given the sample size, restricted randomisation will be performed using a permuted block design and allocation within blocks in a 1:1 ratio and sequence of blocks determined using the “random allocation” function of STATA version 11.2 (College Station, Texas).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is estimated that a sample size of 20 participants in each group would provide >90% power to detect a within-group and between-group change in FGF23 from baseline of at least 0.8 times the standard deviation of the mean baseline FGF23 concentration.
Skewed data will be log-transformed before statistical computations. Measurements at Study Days -14, -7 and 0 will be used to estimate pre-infusion week-to-week variation in FGF23. For the primary analysis of mean changes from baseline (mean pre-infusion concentration) in FGF23, we will use restricted maximum likelihood-based repeated measures analyses (linear mixed models) that consider random time effects with baseline values treated as a fixed covariate. The models will employ an unstructured covariance design without imputing missing values. Within-group differences between time points may also be evaluated with repeated measures ANOVA, Friedman’s ANOVA or with paired t-tests depending on data distribution. The association between iron indices and baseline and change in FGF23 concentrations will be assessed with Pearson’s or Spearman’s test, as appropriate. Changes from baseline to each scheduled evaluation and to the minimum, maximum, and final value will be compared to zero with Wilcoxon signed-ranks tests. A two-tailed P value <0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
3/04/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
30/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289230 0
Hospital
Name [1] 289230 0
Eastern Health Integrated Renal Service
Country [1] 289230 0
Australia
Funding source category [2] 289258 0
Commercial sector/Industry
Name [2] 289258 0
Vifor Pharma Pty Ltd
Country [2] 289258 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health Integrated Renal Service
Address
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 287903 0
None
Name [1] 287903 0
Address [1] 287903 0
Country [1] 287903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290999 0
Eastern Health
Ethics committee address [1] 290999 0
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Ethics committee country [1] 290999 0
Australia
Date submitted for ethics approval [1] 290999 0
24/09/2013
Approval date [1] 290999 0
25/02/2014
Ethics approval number [1] 290999 0
E13/1314

Summary
Brief summary
The goal of this randomised controlled trial is to examine the effects of iron deficiency and compare its correction with either IV ferric carboxymaltose or iron sucrose on intact fibroblast growth factor 23 (FGF23)concentrations in individuals with end stage kidney disease undergoing chronic haemodialysis therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48398 0
Dr Matthew Roberts
Address 48398 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 48398 0
Australia
Phone 48398 0
+61 3 9091 8872
Fax 48398 0
+61 3 9899 6810
Email 48398 0
matthew.roberts@easternhealth.org.au
Contact person for public queries
Name 48399 0
Dr Matthew Roberts
Address 48399 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 48399 0
Australia
Phone 48399 0
+61 3 9091 8872
Fax 48399 0
+61 3 9899 6810
Email 48399 0
matthew.roberts@easternhealth.org.au
Contact person for scientific queries
Name 48400 0
Dr Matthew Roberts
Address 48400 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 48400 0
Australia
Phone 48400 0
+61 3 9091 8872
Fax 48400 0
+61 3 9899 6810
Email 48400 0
matthew.roberts@easternhealth.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
EmbaseEffects of intravenous iron on fibroblast growth factor 23 (FGF23) in haemodialysis patients: A randomized controlled trial.2016https://dx.doi.org/10.1186/s12882-016-0391-7
N.B. These documents automatically identified may not have been verified by the study sponsor.