Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease (EMAN-Anaemia)
- To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
- To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
- To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.
|Study Design:||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|
- Haemoglobin [ Time Frame: 12 months ]Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.
- All Cause Hospitalisation [ Time Frame: 12 months ]Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations
- Outpatient Review Numbers [ Time Frame: 12 months ]
- Primary Care review Numbers [ Time Frame: 12 months ]
- Cardiovascular Hospitalisation [ Time Frame: 12 months ]
- Cerebrovascular Hospitalisation [ Time Frame: 12 months ]
- Peripheral Vascular Hospitalisation [ Time Frame: 12 months ]
- Thrombosis Events [ Time Frame: 12 months ]Venous and Arterial
- Renal Replacement Therapy Commencement [ Time Frame: 12 months ]Dialysis and Renal transplantation
- Deaths [ Time Frame: 12 months ]
- Quality of Life [ Time Frame: 12 months ]
- Missed Doses of ESA [ Time Frame: 12 months ]
- Fe Targets [ Time Frame: 12 months ]
- Blood Transfusion Numbers [ Time Frame: 12 months ]
- Fe Transfusion Numbers [ Time Frame: 12 months ]
- Total Adverse Events [ Time Frame: 12 months ]
- Anaemia Co-Ordinator Time [ Time Frame: 12 months ]
- Pharmacy Time [ Time Frame: 12 months ]
- Courier Costs [ Time Frame: 12 months ]
- Ambulance Transfer Numbers [ Time Frame: 12 months ]
- 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
- Sub-Analysis of Outcomes by ESA Type [ Time Frame: 12 months ]
|Study Start Date:||December 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: EMAN
Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required
See details on ESA Synchronization and Dosing in Detailed Description Above
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763242
|Footscray, Victoria, Australia, 3011|
|Principal Investigator:||Craig L Nelson, MBBSFRACPPhD||Western Health, Australia|