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NCT00048035 · ClinicalTrials.gov registry record · Phase 2
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT00048035: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00048035 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048035, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
Primary Outcome
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a d
Interventions
- DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2002-03 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
What the finished NCT00048035 record still lists
NCT00048035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which methoxy polyethylene glycol-epoetin beta [Mircera] is the first listed.
NCT00048035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048035 about?
NCT00048035 is a clinical study titled "A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia". This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 ind...
What is the current status of trial NCT00048035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2002-03. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00048035?
The interventions under investigation include: methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG).
Who is sponsoring clinical trial NCT00048035?
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 NCT00048035's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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