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NCT00442702 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
NCT00442702: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00442702 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 228 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00442702, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
Study Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome
A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluatio
Interventions
- DRUG Darbepoetin alfa
- DRUG Mircera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
What the finished NCT00442702 record still lists
NCT00442702 is an interventional study that assigns participants to a tested intervention. The registered 228 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 (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Darbepoetin alfa is the first listed.
NCT00442702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00442702 about?
NCT00442702 is a clinical study titled "A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.". This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on da...
What is the current status of trial NCT00442702?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2007-09. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00442702?
The interventions under investigation include: Darbepoetin alfa (DRUG), Mircera (DRUG).
Who is sponsoring clinical trial NCT00442702?
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 NCT00442702's enrollment target sits among peer trials
228 1309th of 2000 higher than 691 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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