AnemiaPhase 1NCT01428154
Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
A Phase 1 study testing Darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Amgen.
Trial summary
The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking… Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- Phase
- Phase 1
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Girls and boys between birth and < 1 year of age at the time of enrollment
- Body weight ≥ 3 kg at screening and enrollment
- Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
- Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment
- Transferrin saturation ≥ 20% at screening
Who cannot join
- Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period)
- Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
- History of cardiovascular events or thromboembolism
- History of upper or lower gastrointestinal bleeding
- History of seizures
- Active liver disease or history of liver disease
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- Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age
- Major surgery 12 weeks prior to enrollment
- Red blood cell transfusions 12 weeks prior to enrollment
- Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment
- Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment
- Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as ≤ 0.5 mg/kg per day prednisone or equivalent for ≤ 5 days)
- Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to enrollment
- Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment
- Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients
About this study
Official title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin Alfa in Paediatric Subjects From Birth to Less Than 1 Year of Age With Anemia Due to Chronic Kidney Disease
The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.
Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.
- Conditions
- Anemia, Chronic Kidney Disease
- Being tested
- Darbepoetin alfa
- Keywords
- paediatric, dialysis, CKD, pediatric
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Aranesp
A single 1.5 μg/kg subcutaneous (SC) dose administration on day 1
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Experimental | Not described Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs
Measured: Assessed over 29 days
Number of subjects with treatment-emergent adverse events
Measured: Assessed over 29 days
Secondary outcomes (12)
Maximum observed concentration (Cmax) of darbepoetin alfa
Measured: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Time at which maximum concentration is observed (Tmax) of darbepoetin alfa
Measured: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Area under the concentration curve (AUC) of darbepoetin alfa
Measured: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Terminal half-life (t½) of darbepoetin alfa
Measured: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Clearance (CL) of darbepoetin alfa
Measured: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Change in reticulocytes
Measured: Assessed from baseline to day 8
Change in reticulocytes
Measured: Assessed from baseline to day 29
Change in hemoglobin concentration
Measured: Assessed from baseline to day 8
Change in hemoglobin concentration
Measured: Assessed from baseline to day 29
Change in iron
Measured: Assessed from baseline to day 29
Change in ferritin
Measured: Assessed from baseline to day 29
Change in transferrin saturation
Measured: Assessed from baseline to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startApr 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age.
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428154
- Sponsor's protocol ID
- 20090302
- Status last verified
- Jun 2016
- First submitted
- 1 Sep 2011
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin Alfa in Paediatric Subjects From Birth to Less Than 1 Year of Age With Anemia Due to Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01428154
- Acronym / sponsor ID
- 20090302
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- paediatric, dialysis, CKD, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Sep 2011 (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 find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.
Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | Experimental | Drug: Darbepoetin alfa |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Girls and boys between birth and < 1 year of age at the time of enrollment
- Body weight ≥ 3 kg at screening and enrollment
- Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
- Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment
- Transferrin saturation ≥ 20% at screening
Key exclusion criteria (15 listed)
- Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period)
- Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
- History of cardiovascular events or thromboembolism
- History of upper or lower gastrointestinal bleeding
- History of seizures
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 |
|---|---|---|
| Darbepoetin alfaAlso: AranespA single 1.5 μg/kg subcutaneous (SC) dose administration on day 1 | Drug | Darbepoetin alfa |
Primary outcome
Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs
Time frame: Assessed over 29 days
Number of subjects with treatment-emergent adverse events
Time frame: Assessed over 29 days
12 secondary outcomes
Maximum observed concentration (Cmax) of darbepoetin alfa
Time frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Time at which maximum concentration is observed (Tmax) of darbepoetin alfa
Time frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Area under the concentration curve (AUC) of darbepoetin alfa
Time frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Terminal half-life (t½) of darbepoetin alfa
Time frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Clearance (CL) of darbepoetin alfa
Time frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose
Change in reticulocytes
Time frame: Assessed from baseline to day 8
Change in reticulocytes
Time frame: Assessed from baseline to day 29
Change in hemoglobin concentration
Time frame: Assessed from baseline to day 8
Change in hemoglobin concentration
Time frame: Assessed from baseline to day 29
Change in iron
Time frame: Assessed from baseline to day 29
Change in ferritin
Time frame: Assessed from baseline to day 29
Change in transferrin saturation
Time frame: Assessed from baseline to day 29
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- 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 1 study testing Darbepoetin alfa in people with Anemia and 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?
The sponsor lists 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Jun 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs (time frame: Assessed over 29 days). The study lists 2 primary outcomes in all. 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 17 Jun 2016.