Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Western Health, Australia
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
