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

Sponsor

Western Health, Australia (Other)

Overall Status

Completed

CT.gov ID

NCT01763242

Collaborator

(none)

102

Enrollment

Location

Arms

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Anemia	Other: EMAN	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Haemoglobin [12 months]
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 [12 months]
Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations
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 [12 months]
Venous and Arterial
Renal Replacement Therapy Commencement [12 months]
Dialysis and Renal transplantation
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 [12 months]
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 [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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