AnemiaPhase 4NCT01975844
The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
A Phase 4 study testing Individualized Anemia Mangement Protocol in people with Anemia and End Stage Renal Disease, run by Michael Germain at 1 site in United States.
Trial summary
Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target Objectives: 1. Decreased variability of Hgb 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, End Stage Renal Disease
- What is being tested?
- Individualized Anemia Mangement Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2014
- 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
- 18 years old or older
- Receiving hemodialysis in an out-patient dialysis unit
Who cannot join
- Not receiving EPOGEN as part of their standard medical care
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicopee Dialysis Center
Chicopee, Massachusetts, 01013
About this study
Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target
Objectives:
- Decreased variability of Hgb
- Increase the % of patients in target range c Increase in time that Hgb remains target range
Read the detailed description
Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.
The individual AMP will be utilized weekly during the 9 months of Phase 2.
The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.
All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.
- Conditions
- Anemia, End Stage Renal Disease
- Being tested
- Individualized Anemia Mangement Protocol
- Keywords
- Anemia, End Stage Renal Disease
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Anemia Mangement ProtocolOther
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP .
| Study group | Role | What they receive |
|---|---|---|
| Individualized Anemia Mangement Protocol | Experimental | Single arm study, therefore all patients will participate in the following:
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP . Receives: Other: Individualized Anemia Mangement Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraindividual Hemoglobin (Hgb) variability
Change in average intraindividual Hgb variability between control period and treatment periods.
Measured: Evaluated and updated weekly for 52 weeks
Secondary outcomes (1)
Average hemoglobin levels
Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods.
Measured: Evaluated and updated weekly for 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
Why it stopped: Study has been terminated due to lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Germain
- Sponsor type
- University, hospital or other
- Collaborators
- Western New England Renal & Transplant Associates, PC
- Responsible party
- Sponsor-investigator, Michael Germain, Baystate Medical Center
- Investigators
- Michael J Germain, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975844
- Sponsor's protocol ID
- BH-12-197
- Status last verified
- Mar 2014
- First submitted
- 13 Aug 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
- ClinicalTrials.gov ID
- NCT01975844
- Acronym / sponsor ID
- BH-12-197
- Conditions
- Anemia, End Stage Renal Disease
- Keywords
- Anemia, End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated due to lack of financial support
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Michael GermainUniversity, hospital or other
- Collaborators
- Western New England Renal & Transplant Associates, PC
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 5 Nov 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.
Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target
Objectives:
- Decreased variability of Hgb
- Increase the % of patients in target range c Increase in time that Hgb remains target range
Detailed description
Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.
The individual AMP will be utilized weekly during the 9 months of Phase 2.
The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.
All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized Anemia Mangement Protocol | Experimental | Other: Individualized Anemia Mangement ProtocolSingle arm study, therefore all patients will participate in the following: Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older
- Receiving hemodialysis in an out-patient dialysis unit
Key exclusion criteria (2 listed)
- Not receiving EPOGEN as part of their standard medical care
- Patient refusal
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 |
|---|---|---|
| Individualized Anemia Mangement ProtocolPhase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP . | Other | Individualized Anemia Mangement Protocol |
Primary outcome
Intraindividual Hemoglobin (Hgb) variability
Time frame: Evaluated and updated weekly for 52 weeks
Change in average intraindividual Hgb variability between control period and treatment periods.
1 secondary outcome
Average hemoglobin levels
Time frame: Evaluated and updated weekly for 52 weeks
Results and safety
The study was stopped early (reason given: Study has been terminated due to lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Michael J Germain, MD principal investigator
Baystate Medical Center
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 Individualized Anemia Mangement Protocol in people with Anemia and End Stage Renal Disease, run by Michael Germain at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Mar 2014. 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 United States. 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 was stopped early (reason given: Study has been terminated due to lack of financial support). Results are not available in the source record.
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?
Intraindividual Hemoglobin (Hgb) variability (time frame: Evaluated and updated weekly for 52 weeks). 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 26 Mar 2014.