Kidney Failure, ChronicPhase 4EMAN-AnaemiaNCT01763242
Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease
A Phase 4 study testing EMAN in people with Kidney Failure, Chronic and Anemia, run by Western Health, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Anemia
- What is being tested?
- EMAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age > 18 years
- Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- EMAN
- Keywords
- CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMANOther
Also called Synchronised Blood Testing, Electronic upload of Blood Results, Synchronised ESA dosing monthly, Home delivery of ESA
See details on ESA Synchronization and Dosing in Detailed Description Above
| Study group | Role | What they receive |
|---|---|---|
| EMAN | Active comparator | Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required Receives: Other: EMAN |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin
Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.
Measured: 12 months
Secondary outcomes (20)
All Cause Hospitalisation
Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations
Measured: 12 months
Outpatient Review Numbers
Measured: 12 months
Primary Care review Numbers
Measured: 12 months
Cardiovascular Hospitalisation
Measured: 12 months
Cerebrovascular Hospitalisation
Measured: 12 months
Peripheral Vascular Hospitalisation
Measured: 12 months
Thrombosis Events
Venous and Arterial
Measured: 12 months
Renal Replacement Therapy Commencement
Dialysis and Renal transplantation
Measured: 12 months
Deaths
Measured: 12 months
Quality of Life
Measured: 12 months
Missed Doses of ESA
Measured: 12 months
Fe Targets
Measured: 12 months
Blood Transfusion Numbers
Measured: 12 months
Fe Transfusion Numbers
Measured: 12 months
Total Adverse Events
Measured: 12 months
Anaemia Co-Ordinator Time
Measured: 12 months
Pharmacy Time
Measured: 12 months
Courier Costs
Measured: 12 months
Ambulance Transfer Numbers
Measured: 12 months
Cardiac and Vascular Biomarker Analysis
N Terminal Pro-Brain Natruretic Peptide, Interleukin-6, Tumour Necrosis Factor alpha, High Sensitivity C Reactive Protein
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Health, Australia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Craig Nelson, Western Health, Australia
- Investigators
- Craig L Nelson, MBBSFRACPPhD, Principal investigator, Western Health, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763242
- Sponsor's protocol ID
- HREC: 2010.267
- Acronym
- EMAN-Anaemia
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2013
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01763242
- Acronym / sponsor ID
- EMAN-Anaemia / HREC: 2010.267
- Conditions
- Kidney Failure, Chronic, Anemia
- Keywords
- CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Western Health, AustraliaOther government
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMAN | Active comparator | Other: EMANElectronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age > 18 years
- Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMANAlso: Synchronised Blood Testing, Electronic upload of Blood Results, Synchronised ESA dosing monthly, Home delivery of ESASee details on ESA Synchronization and Dosing in Detailed Description Above | Other | EMAN |
Primary outcome
Haemoglobin
Time frame: 12 months
Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.
20 secondary outcomes
All Cause Hospitalisation
Time frame: 12 months
Outpatient Review Numbers
Time frame: 12 months
Primary Care review Numbers
Time frame: 12 months
Cardiovascular Hospitalisation
Time frame: 12 months
Cerebrovascular Hospitalisation
Time frame: 12 months
Peripheral Vascular Hospitalisation
Time frame: 12 months
Thrombosis Events
Time frame: 12 months
Renal Replacement Therapy Commencement
Time frame: 12 months
Deaths
Time frame: 12 months
Quality of Life
Time frame: 12 months
Missed Doses of ESA
Time frame: 12 months
Fe Targets
Time frame: 12 months
Blood Transfusion Numbers
Time frame: 12 months
Fe Transfusion Numbers
Time frame: 12 months
Total Adverse Events
Time frame: 12 months
Anaemia Co-Ordinator Time
Time frame: 12 months
Pharmacy Time
Time frame: 12 months
Courier Costs
Time frame: 12 months
Ambulance Transfer Numbers
Time frame: 12 months
Cardiac and Vascular Biomarker Analysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig L Nelson, MBBSFRACPPhD principal investigator
Western Health, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMAN in people with Kidney Failure, Chronic and Anemia, run by Western Health, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.