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

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

Aims:

1. To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
2. To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
3. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

Study Overview

• Status: Completed
• Conditions: Anemia; Kidney Failure, Chronic
• Intervention / Treatment: Other: EMAN

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Western Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Quality of Life		12 months
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
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

Other Outcome Measures

Outcome Measure	Time Frame
Sub-Analysis of Outcomes by ESA Type	12 months

Collaborators and Investigators

• Sponsor: Western Health, Australia
• Investigators: Principal Investigator: Craig L Nelson, MBBSFRACPPhD, Western Health, Australia

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 6, 2013
• First Submitted That Met QC Criteria: January 6, 2013
• First Posted (ESTIMATE): January 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Anemia
• Other Study ID Numbers: HREC: 2010.267