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NCT00077623 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 572
- Enrollment target
NCT00077623: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00077623 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 572 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077623, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 572 participants
- Enrollment target
Study Summary
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Primary Outcome
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values t
Interventions
- DRUG epoetin alfa or beta
- DRUG methoxy polyethylene glycol-epoetin beta (Mircera)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2004-03 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
What the finished NCT00077623 record still lists
NCT00077623 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which epoetin alfa or beta is the first listed.
NCT00077623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00077623 about?
NCT00077623 is a clinical study titled "A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.". This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-...
What is the current status of trial NCT00077623?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 572 participants. The study started on 2004-03. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00077623?
The interventions under investigation include: epoetin alfa or beta (DRUG), methoxy polyethylene glycol-epoetin beta (Mircera) (DRUG).
Who is sponsoring clinical trial NCT00077623?
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 NCT00077623's enrollment target sits among peer trials
572 663rd of 2000 higher than 1,336 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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