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NCT00090753 · ClinicalTrials.gov registry record · Phase 3
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,228
- Enrollment target
NCT00090753: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00090753 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,228 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00090753, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,228 participants
- Enrollment target
Study Summary
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
Primary Outcome
Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
Interventions
- DRUG Epoetin alfa
- DRUG Darbepoetin alfa
- DRUG Methoxy Polyethylene Glycol-Epoetin Beta
- DRUG Epoetin beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,228 participants |
| Start Date | 2004-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00090753 record still lists
NCT00090753 is an interventional study that assigns participants to a tested intervention. Its 1,228 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 4 interventions - of which Epoetin alfa is the first listed.
NCT00090753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00090753 about?
NCT00090753 is a clinical study titled "A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia". This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyeth...
What is the current status of trial NCT00090753?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,228 participants. The study started on 2004-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00090753?
The interventions under investigation include: Epoetin alfa (DRUG), Darbepoetin alfa (DRUG), Methoxy Polyethylene Glycol-Epoetin Beta (DRUG), Epoetin beta (DRUG).
Who is sponsoring clinical trial NCT00090753?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00090753's enrollment target sits among peer trials
1,228 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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