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

Study Overview
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Brief Summary
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Aims: 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.

Detailed Description
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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.

Official Title
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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

Conditions
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Kidney Failure, Chronic, Anemia

Intervention / Treatment
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* Other: EMAN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMAN<br>Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required | Other: EMAN<br>* See details on ESA Synchronization and Dosing in Detailed Description Above<br>* Other names: Home delivery of ESA;|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin | Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Hospitalisation | Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations | 12 months | 
| Outpatient Review Numbers |  | 12 months | 
| Primary Care review Numbers |  | 12 months | 
| Cardiovascular Hospitalisation |  | 12 months | 
| Cerebrovascular Hospitalisation |  | 12 months | 
| Peripheral Vascular Hospitalisation |  | 12 months | 
| Thrombosis Events | Venous and Arterial | 12 months | 
| Renal Replacement Therapy Commencement | Dialysis and Renal transplantation | 12 months | 
| Deaths |  | 12 months | 
| Quality of Life |  | 12 months | 
| Missed Doses of ESA |  | 12 months | 
| Fe Targets |  | 12 months | 
| Blood Transfusion Numbers |  | 12 months | 
| Fe Transfusion Numbers |  | 12 months | 
| Total Adverse Events |  | 12 months | 
| Anaemia Co-Ordinator Time |  | 12 months | 
| Pharmacy Time |  | 12 months | 
| Courier Costs |  | 12 months | 
| Ambulance Transfer Numbers |  | 12 months | 
| Cardiac and Vascular Biomarker Analysis | N Terminal Pro-Brain Natruretic Peptide, Interleukin-6, Tumour Necrosis Factor alpha, High Sensitivity C Reactive Protein | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery