A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Public ClinicalTrials.gov record NCT00442702. 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
An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study identification
- NCT ID
- NCT00442702
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 228 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 2007 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Aug 2010 (Actual)
- Last update posted
- Dec 19, 2011
2007 – 2010
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Granada Hills | California | 91344 | — |
| Not listed | Lauderdale Lakes | Florida | 33313 | — |
| Not listed | Augusta | Georgia | 30309 | — |
| Not listed | Mineola | New York | 11501 | — |
| Not listed | Orchard Park | New York | 14127 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Oregon City | Oregon | 97045 | — |
| Not listed | Providence | Rhode Island | 02903 | — |
| Not listed | Chattanooga | Tennessee | 37404 | — |
| Not listed | Salem | Virginia | 24153 | — |
| Not listed | Morgantown | West Virginia | 26506 | — |
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 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00442702, 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 Dec 19, 2011 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00442702 live on ClinicalTrials.gov.