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NCT00077610 · ClinicalTrials.gov registry record · Phase 3

A Study of Intravenous 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
673
Enrollment target

NCT00077610: Completed Phase 3 study, sponsored by Hoffmann-La Roche.

NCT00077610 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 673 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00077610, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
673 participants
Enrollment target

Study Summary

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv 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 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 from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 el

Interventions

  • DRUG Epoetin alfa or beta
  • DRUG RO0503821 (1x/2 Weeks)
  • DRUG RO0503821 (1x/4 Weeks)

Trial Details

FieldValue
Enrollment Target 673 participants
Start Date 2004-02
Est. Completion 2005-08
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT00077610 record still lists

NCT00077610 is an interventional study that assigns participants to a tested intervention. The registered 673 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 (13% lower).

The record links to 0 conditions, and to 3 interventions - of which Epoetin alfa or beta is the first listed.

NCT00077610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00077610 about?

NCT00077610 is a clinical study titled "A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients". This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 i...

What is the current status of trial NCT00077610?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 673 participants. The study started on 2004-02. Estimated completion is 2005-08.

What interventions are being tested in trial NCT00077610?

The interventions under investigation include: Epoetin alfa or beta (DRUG), RO0503821 (1x/2 Weeks) (DRUG), RO0503821 (1x/4 Weeks) (DRUG).

Who is sponsoring clinical trial NCT00077610?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00077610's enrollment target sits among peer trials

673 544th of 2000 higher than 1,457 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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Source: ClinicalTrials.gov NCT00077610, the US trial registry maintained by the National Library of Medicine. NCT00077610 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.