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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Craig Nelson, Western Health, Australia
ClinicalTrials.gov Identifier:
NCT01763242
First received: January 6, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Kidney Failure, Chronic
Anemia
Other: EMAN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Western Health, Australia:

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


Secondary Outcome Measures:
  • All Cause Hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations

  • Outpatient Review Numbers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Primary Care review Numbers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular Hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cerebrovascular Hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Peripheral Vascular Hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Thrombosis Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Venous and Arterial

  • Renal Replacement Therapy Commencement [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Dialysis and Renal transplantation

  • Deaths [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Missed Doses of ESA [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Fe Targets [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Blood Transfusion Numbers [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Fe Transfusion Numbers [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Total Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Anaemia Co-Ordinator Time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacy Time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Courier Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ambulance Transfer Numbers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiac and Vascular Biomarker Analysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    N Terminal Pro-Brain Natruretic Peptide, Interleukin-6, Tumour Necrosis Factor alpha, High Sensitivity C Reactive Protein


Other Outcome Measures:
  • Sub-Analysis of Outcomes by ESA Type [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%

Statistics:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763242

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

No publications provided

Responsible Party: Dr Craig Nelson, Head of Unit - Nephrology, Western Health, Australia
ClinicalTrials.gov Identifier: NCT01763242     History of Changes
Other Study ID Numbers: HREC: 2010.267
Study First Received: January 6, 2013
Last Updated: January 6, 2013
Health Authority: Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014