Chronic Renal FailurePhase 4NCT01111630
Study of Erythropoietin (EPO) Administration Schedule
A Phase 4 study testing recomon (Epoetin Beta) in people with Chronic Renal Failure and Anaemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Renal Failure, Anaemia
- What is being tested?
- recomon (Epoetin Beta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80.
- Dialysis for at least 3 months.
- Epoetin treatment for the last 3 months.
- Baseline hemoglobin (Hb) value of >= 9.0 g/dL and < 13.0 g/dL.
- Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
- Patients who agree to participate in this study in writing.
Who cannot join
- Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
- Hemolysis as defined
- Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
- Patients with uncontrolled hypertension.
- Acute infection of unstable systemic inflammatory disease.
- Current malignant disease.
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- High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
- Life expectancy below 12 months.
- Planned elective surgery during the study period.
- Blood transfusions within the last 3 months.
- Pregnancy and lactation.
- Other conditions regarded as unsuitability by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.
- Conditions
- Chronic Renal Failure, Anaemia
- Being tested
- recomon (Epoetin Beta)
- Keywords
- chronic renal failure, Anaemia
- 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.
recomon (Epoetin Beta)Drug
administer once weekly
recomon (Epoetin Beta)Drug
administer three times weekly
| Study group | Role | What they receive |
|---|---|---|
| once weekly | Experimental | Not described Receives: Drug: recomon (Epoetin Beta) |
| three times weekly | Active comparator | Not described Receives: Drug: recomon (Epoetin Beta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hemoglobin variability between once & three times weekly administration
Measured: 24 weeks
Secondary outcomes (6)
The hematocrit variability between once & three times weekly administration
Measured: 24 weeks
Mean value of Hb and Hct between once & three times weekly administration
Measured: 24 weeks
Drop out rate during dose fix period
Measured: 24 weeks
Mean value of Hb and Hct during dose fix period
Measured: 24 weeks
Variability of Hb and Hct during dose fix period
Measured: 24weeks
Weekly oetin-beta maintenance dose between once & three times weekly administration
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SugKyun Shin, Ph.D., Principal investigator, National Health Insurance Service Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111630
- Sponsor's protocol ID
- CWP_RCM_R01
- Status last verified
- May 2014
- First submitted
- 25 Apr 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT01111630
- Acronym / sponsor ID
- CWP_RCM_R01
- Conditions
- Chronic Renal Failure, Anaemia
- Keywords
- chronic renal failure, Anaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Apr 2010 (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.
The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| once weekly | Experimental | Drug: recomon (Epoetin Beta) |
| three times weekly | Active comparator | Drug: recomon (Epoetin Beta) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 80.
- Dialysis for at least 3 months.
- Epoetin treatment for the last 3 months.
- Baseline hemoglobin (Hb) value of >= 9.0 g/dL and < 13.0 g/dL.
- Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
Key exclusion criteria (12 listed)
- Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
- Hemolysis as defined
- Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
- Patients with uncontrolled hypertension.
- Acute infection of unstable systemic inflammatory disease.
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 |
|---|---|---|
| recomon (Epoetin Beta)administer once weekly | Drug | once weekly |
| recomon (Epoetin Beta)administer three times weekly | Drug | three times weekly |
Primary outcome
The hemoglobin variability between once & three times weekly administration
Time frame: 24 weeks
6 secondary outcomes
The hematocrit variability between once & three times weekly administration
Time frame: 24 weeks
Mean value of Hb and Hct between once & three times weekly administration
Time frame: 24 weeks
Drop out rate during dose fix period
Time frame: 24 weeks
Mean value of Hb and Hct during dose fix period
Time frame: 24 weeks
Variability of Hb and Hct during dose fix period
Time frame: 24weeks
Weekly oetin-beta maintenance dose between once & three times weekly administration
Time frame: 24 weeks
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 14 May 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.
SugKyun Shin, Ph.D. principal investigator
National Health Insurance Service Ilsan Hospital
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 recomon (Epoetin Beta) in people with Chronic Renal Failure and Anaemia, run by JW Pharmaceutical at 1 site in South Korea.
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 6 inclusion and 12 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 14 May 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 South Korea. 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?
The hemoglobin variability between once & three times weekly administration (time frame: 24 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 14 May 2014.