Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
Public ClinicalTrials.gov record NCT00436748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00436748
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 116 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 16, 2008 (Actual)
- Primary completion
- Mar 3, 2014 (Actual)
- Completion
- Mar 3, 2014 (Actual)
- Last update posted
- Nov 29, 2022
2008 – 2014
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | — |
| Research Site | Los Angeles | California | 90027 | — |
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Stanford | California | 94305-5208 | — |
| Research Site | Washington D.C. | District of Columbia | 20010 | — |
| Research Site | Gainesville | Florida | 32610 | — |
| Research Site | Miami | Florida | 33136 | — |
| Research Site | Orlando | Florida | 32806 | — |
| Research Site | Boise | Idaho | 83712 | — |
| Research Site | Chicago | Illinois | 60612 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | New Orleans | Louisiana | 70118 | — |
| Research Site | Baltimore | Maryland | 21287 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | Kansas City | Missouri | 64108 | — |
| Research Site | Livingston | New Jersey | 07039 | — |
| Research Site | New Brunswick | New Jersey | 08901 | — |
| Research Site | Albuquerque | New Mexico | 87131 | — |
| Research Site | Buffalo | New York | 14222 | — |
| Research Site | New Hyde Park | New York | 11040 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | The Bronx | New York | 10467 | — |
| Research Site | Valhalla | New York | 10595 | — |
| Research Site | Charlotte | North Carolina | 28203 | — |
| Research Site | Akron | Ohio | 44308 | — |
| Research Site | Cincinnati | Ohio | 45229 | — |
| Research Site | Cleveland | Ohio | 44106 | — |
| Research Site | Cleveland | Ohio | 44195 | — |
| Research Site | Columbus | Ohio | 43205 | — |
| Research Site | Portland | Oregon | 97227 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Dallas | Texas | 75390 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Charlottesville | Virginia | 22908 | — |
| Research Site | Norfolk | Virginia | 23507 | — |
| Research Site | Richmond | Virginia | 23219 | — |
| Research Site | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00436748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 29, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00436748 live on ClinicalTrials.gov.