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NCT00436748 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT00436748 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 116 participants.
The verdict
NCT00436748, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study Summary
The primary objectives of this study are the following: 1. To test if the proportion of participants 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 once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of participants 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 every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.
Interventions
- DRUG Placebo
- DRUG Darbepoetin Alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2008-09-16 |
| Est. Completion | 2014-03-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00436748
The ClinicalTrials.gov registry entry for NCT00436748 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00436748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00436748 about?
NCT00436748 is a clinical study titled "Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease". The primary objectives of this study are the following: 1. To test if the proportion of participants 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 once a week (QW...
What is the current status of trial NCT00436748?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2008-09-16. Estimated completion is 2014-03-03.
What interventions are being tested in trial NCT00436748?
The interventions under investigation include: Placebo (DRUG), Darbepoetin Alfa (DRUG).
Who is sponsoring clinical trial NCT00436748?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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