Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease (EMAN-Anaemia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01763242
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Dr Craig Nelson, Western Health, Australia

Brief Summary:


  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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Anemia Other: EMAN Phase 4

Detailed Description:

CKD Stages 3 to 5 Subjects will be randomised and stratified according to Age, Gender, CKD Stage, Known Cardiovascular Disease, Diabetes and ESA Type into EMAN vs. Control

Details of EMAN synchronization and Dosing:

Monthly dose of ESA is calculated by:

Monthly dose = present dose x (28/present frequency (days))

Synchronization will be achieved by using the formula: "Synchronization dose of ESA = (28-Days until next injection is due)/28 x monthly dose of ESA

The dose of ESA/C.E.R.A. should be adjusted to maintain the individual patient's haemoglobin within a range of 11± 1.0 g/dL of the reference haemoglobin concentration ie. between 10.0 and 12.0 g/dL

Haemoglobin Value Corrective Adjustment

  • A single value >13 g/dL Interrupt treatment until Hb falls below 12 g/dL then re-start treatment at 50% of previous dose
  • A single value <9 g/dL Increase dose by 50%
  • Difference between two consecutive Hb values indicates ≥2 g/dL increase Reduce dose by 50%
  • Difference between two consecutive Hb values indicates ≥2 g/dL decrease Increase dose by 50%
  • >11.5 g/dL and <13 g/dL AND deviation from reference value is >1g/dL. Reduce dose by 25%
  • <10.5 g/dL and >9 g/dL AND deviation from reference value is >1g/dL. Increase dose by 25%
  • >12 g/dL Reduce dose by 25%
  • <10 g/dL Increase dose by 25%


Audit of present practice suggests CKD patients achieve only 30% on target (Hb 10-12g/dL) while well audited dialysis units in our service can achieve 60% at target.

If an improvement from 30% to 60% is expected in the EMAN verses Control arm then 100 patients (50 in each group) would be required to show a significant difference p<0.05 with 85% power.

Patients will be analysed on an intention to treat basis Primary and Secondary Endpoint data will be compared between study and control groups using unpaired student t-tests after normalisation of data as required and/or chi squared analysis.

Statistical significance will be taken at p<0.05.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: EMAN
Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required
Other: EMAN
See details on ESA Synchronization and Dosing in Detailed Description Above
Other Names:
  • Synchronised Blood Testing
  • Electronic upload of Blood Results
  • Synchronised ESA dosing monthly
  • Home delivery of ESA
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

Primary Outcome Measures :
  1. Haemoglobin [ Time Frame: 12 months ]
    Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.

Secondary Outcome Measures :
  1. All Cause Hospitalisation [ Time Frame: 12 months ]
    Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations

  2. Outpatient Review Numbers [ Time Frame: 12 months ]
  3. Primary Care review Numbers [ Time Frame: 12 months ]
  4. Cardiovascular Hospitalisation [ Time Frame: 12 months ]
  5. Cerebrovascular Hospitalisation [ Time Frame: 12 months ]
  6. Peripheral Vascular Hospitalisation [ Time Frame: 12 months ]
  7. Thrombosis Events [ Time Frame: 12 months ]
    Venous and Arterial

  8. Renal Replacement Therapy Commencement [ Time Frame: 12 months ]
    Dialysis and Renal transplantation

  9. Deaths [ Time Frame: 12 months ]
  10. Quality of Life [ Time Frame: 12 months ]
  11. Missed Doses of ESA [ Time Frame: 12 months ]
  12. Fe Targets [ Time Frame: 12 months ]
  13. Blood Transfusion Numbers [ Time Frame: 12 months ]
  14. Fe Transfusion Numbers [ Time Frame: 12 months ]
  15. Total Adverse Events [ Time Frame: 12 months ]
  16. Anaemia Co-Ordinator Time [ Time Frame: 12 months ]
  17. Pharmacy Time [ Time Frame: 12 months ]
  18. Courier Costs [ Time Frame: 12 months ]
  19. Ambulance Transfer Numbers [ Time Frame: 12 months ]
  20. Cardiac and Vascular Biomarker Analysis [ Time Frame: 12 months ]
    N Terminal Pro-Brain Natruretic Peptide, Interleukin-6, Tumour Necrosis Factor alpha, High Sensitivity C Reactive Protein

Other Outcome Measures:
  1. Sub-Analysis of Outcomes by ESA Type [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Age > 18 years
  • Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01763242

Australia, Victoria
Western Health
Footscray, Victoria, Australia, 3011
Sponsors and Collaborators
Western Health, Australia
Principal Investigator: Craig L Nelson, MBBSFRACPPhD Western Health, Australia

Responsible Party: Dr Craig Nelson, Head of Unit - Nephrology, Western Health, Australia Identifier: NCT01763242     History of Changes
Other Study ID Numbers: HREC: 2010.267
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Dr Craig Nelson, Western Health, Australia:
CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases