A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
Public ClinicalTrials.gov record NCT00442416. 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 Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.
Study identification
- NCT ID
- NCT00442416
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 80 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
- Feb 2007 (Type not available)
- Primary completion
- Jan 2008 (Actual)
- Completion
- Jan 2008 (Actual)
- Last update posted
- Aug 17, 2016
2007 – 2008
United States locations
- U.S. sites
- 29
- U.S. states
- 15
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35213 | — |
| Not listed | Bakersfield | California | 93309 | — |
| Not listed | Chula Vista | California | 91910 | — |
| Not listed | Mountain View | California | 94041 | — |
| Not listed | San Leandro | California | 94578 | — |
| Not listed | Simi Valley | California | 93065 | — |
| Not listed | Whittier | California | 90602 | — |
| Not listed | Lakewood | Colorado | 80214 | — |
| Not listed | Stamford | Connecticut | 06902 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Pembroke Pines | Florida | 33028 | — |
| Not listed | Augusta | Georgia | 30901 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Wichita | Kansas | 67214 | — |
| Not listed | Detroit | Michigan | 48236 | — |
| Not listed | Pontiac | Michigan | 48341 | — |
| Not listed | Flushing | New York | 11355 | — |
| Not listed | Syracuse | New York | 13212 | — |
| Not listed | Williamsville | New York | 14221 | — |
| Not listed | Dayton | Ohio | 45408 | — |
| Not listed | Toledo | Ohio | 43606 | — |
| Not listed | Tulsa | Oklahoma | 74120 | — |
| Not listed | Lewistown | Pennsylvania | 17044 | — |
| Not listed | Philadelphia | Pennsylvania | 19106 | — |
| Not listed | Dyersburg | Tennessee | 38024 | — |
| Not listed | San Antonio | Texas | 78215 | — |
| Not listed | Tyler | Texas | 75701 | — |
| Not listed | Alexandria | Virginia | 22304 | — |
| Not listed | Richmond | Virginia | 23229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00442416, 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 Aug 17, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00442416 live on ClinicalTrials.gov.