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

Phase 4

Completed

• Conditions: Kidney Failure, Chronic; Anemia
• Interventions: Other: EMAN

• Registration Number: NCT01763242
• Lead Sponsor: Western Health, Australia

Brief Summary

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.

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-06
• Study First Submitted QC: 2013-01-06
• Last Update Submitted: 2013-01-06
• Study First Posted: 2013-01-08
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMAN	EMAN	Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Deaths	12 months
Quality of Life	12 months
Missed Doses of ESA	12 months
Fe Targets	12 months
Thrombosis Events	12 months	Venous and Arterial
Renal Replacement Therapy Commencement	12 months	Dialysis and Renal transplantation
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
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

Trial Locations

Locations (1)

Western Health; 🇦🇺 Footscray, Victoria, Australia