Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease

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.

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