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NCT00048048 · ClinicalTrials.gov registry record · Phase 2
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT00048048: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00048048 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048048, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
Primary Outcome
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the
Interventions
- DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2002-03 |
| Est. Completion | 2004-11 |
| Phase | Phase 2 |
What the finished NCT00048048 record still lists
NCT00048048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which methoxy polyethylene glycol-epoetin beta [Mircera] is the first listed.
NCT00048048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048048 about?
NCT00048048 is a clinical study titled "A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.". This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
What is the current status of trial NCT00048048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2002-03. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00048048?
The interventions under investigation include: methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG).
Who is sponsoring clinical trial NCT00048048?
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 NCT00048048's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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