Chronic Kidney DiseasePhase 3NCT00156949
EPO Deep Tank in Dialysis Subjects
A Phase 3 study testing Epoetin alfa DT in people with Chronic Kidney Disease, run by Amgen.
Trial summary
Subject incidence of adverse events Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Epoetin alfa DT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Feb 2007
- Phase
- Phase 3
- 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
Inclusion Criteria: - ≥ 18 years of age - Receiving hemodialysis or peritoneal dialysis - Baseline Hb between 11.0 g/dL and 13.0 g/dL - Currently receiving Epoetin alfa RB ie. EPOGEN or PROCRIT - Transferrin saturation (Tsat) >15.0% Exclusion Criteria: - Currently receiving or ever received treatment with any erythropoietic stimulating protein other than EPOGEN, Procrit and Aranesp. - Uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic BP >180 mmHg during screening). - Grand mal seizure within the last 6 months prior to screening. - Acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment. - Stroke (hemorrhagic or ischemic) or transient ischemic attack within 12 weeks before enrollment. - Major surgery within 3 months prior to screening (excluding vascular access surgery). - Clinical evidence of systemic infection or inflammatory disease at the time of screening and up until enrollment.
For peritoneal dialysis subjects, an episode of peritonitis within 30 days before screening. - Known positivity for HIV antibody or Hepatitis B surface antigen.
Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin. - Blood transfusions within 8 weeks prior to screening or active bleeding. - Androgen therapy within 8 weeks prior to screening.
Systemic hematological disease (eg ,sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - Other investigational products are excluded. - Subject is currently enrolled in, or has not yet completed, a period of at least 30 days since ending other investigational device or drug trial(s).
Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - Pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - Anticipating or scheduled for a living-related kidney transplant. - Known history of severe hyperparathyroidism (PTH >1500pg/ml) within 3 months prior top enrollment. - Currently receiving home hemodialysis treatment. - Currently receiving immunosuppressive therapy.
About this study
Official title: An Open-Label, Single-Arm Study to Assess the Safety of Epoetin Alfa Manufactured by a Deep Tank Technology in Subjects With Chronic Kidney Disease Receiving Dialysis
Subject incidence of adverse events
Read the detailed description
To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have comparable safety profiles when administered to patients with CKD receiving dialysis.
- Conditions
- Chronic Kidney Disease
- Being tested
- Epoetin alfa DT
- Keywords
- Epogen, Procrit, Chronic Kidney Disease, Anemia Treatment for Dialysis Patients
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfa DTDrug
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa DT | Experimental | Not described Receives: Drug: Epoetin alfa DT |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156949
- Sponsor's protocol ID
- 20040268
- Status last verified
- Feb 2010
- First submitted
- 8 Sep 2005
- Last updated
- 19 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study to Assess the Safety of Epoetin Alfa Manufactured by a Deep Tank Technology in Subjects With Chronic Kidney Disease Receiving Dialysis
- ClinicalTrials.gov ID
- NCT00156949
- Acronym / sponsor ID
- 20040268
- Conditions
- Chronic Kidney Disease
- Keywords
- Epogen, Procrit, Chronic Kidney Disease, Anemia Treatment for Dialysis Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Sep 2005 (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.
Subject incidence of adverse events
Detailed description
To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have comparable safety profiles when administered to patients with CKD receiving dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa DT | Experimental | Drug: Epoetin alfa DT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Epoetin alfa DTReceive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL | Drug | Epoetin alfa DT |
Primary outcome
Not reported in the source record.
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 19 Feb 2010.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin alfa DT in people with Chronic Kidney Disease, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 19 Feb 2010.