Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease
Tracking Information| Start Date ICMJE | August 2008 |
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| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: February 20, 2008) | - To test if the proportion of subjects achieving a Hb value >/= 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric CKD subjects receivin [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
- To test if the proportion of subjects achieving a Hb value >/= 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric CKD subjects receiving [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00436748 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: February 20, 2008) | - To assess the safety and tolerability of darbepoetin alfa administered QW and Q2W [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
- To estimate Hb values over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
- To estimate doses over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
- To assess the health-related quality of life in pediatric CKD subjects >/= 2 years old over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
- To obtain pharmacokinetic (PK) data in subjects < 6 years of age [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease |
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| Official Title ICMJE | A Multi-Center, Double-Blind, Randomized Study Evaluating De Novo Weekly and Once Every Two Week Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis |
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| Brief Summary | The primary objectives of this study are the following: - To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis, and
- To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | - Anemia
- Chronic Kidney Disease
- Kidney Disease
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| Intervention ICMJE | - Drug: darbepoetin alfa QW
darbepoetin alfa QW 10, 20, 30, 40, 50, 60, 80, 100, 150, 200, or 300 mcg IV or SC - Drug: darbepoetin alfa Q2W
darbepoetin alfa Q2W 10, 20, 30, 40, 50, 60, 80, 100, 150, 200, or 300 mcg IV or SC
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| Study Arms / Comparison Groups | |
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Recruitment Information| Estimated Enrollment ICMJE | 150 |
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| Estimated Completion Date | November 2012 |
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| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis
- Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL
- Transferrin saturation (Tsat) greater than or equal to 20%
Exclusion Criteria: - Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
- other hematologic disorders
- upper or lower GI bleeding within 6 months prior to randomization
- uncontrolled hypertension
- prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack
- prior history (within 6 months prior to randomization) of thromboembolism
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| Gender | Both |
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| Ages | 1 Year to 18 Years |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: Amgen Call Center | 866-572-6436 | | |
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| Location Countries ICMJE | United States, Belgium, Latvia, Lithuania, Puerto Rico, Russian Federation, Slovakia |
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Administrative Information| NCT ID ICMJE | NCT00436748 |
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| Responsible Party | Global Development Leader, Amgen Inc. |
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| Study ID Numbers ICMJE | 20050256 |
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| Study Sponsor ICMJE | Amgen |
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| Collaborators ICMJE | |
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| Investigators ICMJE | |
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| Information Provided By | Amgen |
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