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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01763242




Registration number
NCT01763242
Ethics application status
Date submitted
6/01/2013
Date registered
8/01/2013
Date last updated
8/01/2013

Titles & IDs
Public title
Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease
Scientific title
EMAN-Anaemia: An Open Labelled Randomised Control Trial of the Synchronized Electronic MANagement of Anaemia in Chronic Kidney Disease (CKD) Compared to Usual Care Anaemia Management
Secondary ID [1] 0 0
HREC: 2010.267
Universal Trial Number (UTN)
Trial acronym
EMAN-Anaemia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Chronic 0 0
Anemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - EMAN

Active comparator: EMAN - Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required

No intervention: Control - Standard Outpatient Care with usual blood tests and follow up, and varied ESA dosing and frequency times. Patients are responsible for collecting their own ESA from Pharmacy


Other interventions: EMAN
See details on ESA Synchronization and Dosing in Detailed Description Above
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Haemoglobin
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
All Cause Hospitalisation
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Outpatient Review Numbers
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Primary Care review Numbers
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Cardiovascular Hospitalisation
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Cerebrovascular Hospitalisation
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Peripheral Vascular Hospitalisation
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Thrombosis Events
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Renal Replacement Therapy Commencement
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Deaths
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Quality of Life
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Missed Doses of ESA
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Fe Targets
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Blood Transfusion Numbers
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Fe Transfusion Numbers
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Total Adverse Events
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Anaemia Co-Ordinator Time
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Pharmacy Time
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Courier Costs
Timepoint [18] 0 0
12 months
Secondary outcome [19] 0 0
Ambulance Transfer Numbers
Timepoint [19] 0 0
12 months
Secondary outcome [20] 0 0
Cardiac and Vascular Biomarker Analysis
Timepoint [20] 0 0
12 months

Eligibility
Key inclusion criteria
* Written informed consent
* Age > 18 years
* Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy
* Significant acute bleeding such as overt gastrointestinal bleeding
* A known haematological cause for anaemia
* Known metastatic malignancy
* Present participation in another interventional clinical trial • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Western Health - Footscray
Recruitment postcode(s) [1] 0 0
3011 - Footscray

Funding & Sponsors
Primary sponsor type
Government body
Name
Western Health, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Aims:

1. To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
2. To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
3. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.
Trial website
https://clinicaltrials.gov/study/NCT01763242
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig L Nelson, MBBSFRACPPhD
Address 0 0
Western Health, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01763242