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

NCT ID: NCT01763242

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Kidney Failure, Chronic; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMAN

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

Group Type: ACTIVE_COMPARATOR

EMAN

Intervention Type: OTHER

See details on ESA Synchronization and Dosing in Detailed Description Above

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMAN

See details on ESA Synchronization and Dosing in Detailed Description Above

Intervention Type: OTHER

Other Intervention Names

Synchronised Blood Testing; Electronic upload of Blood Results; Synchronised ESA dosing monthly; Home delivery of ESA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Health, Australia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Craig Nelson

Head of Unit - Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig L Nelson, MBBSFRACPPhD

Role: PRINCIPAL_INVESTIGATOR

Western Health, Australia

Locations

Western Health

Footscray, Victoria, Australia

Countries

Australia

Other Identifiers

HREC: 2010.267

Identifier Type: -

Identifier Source: org_study_id