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NCT00081484 · ClinicalTrials.gov registry record · Phase 3

A Study of Intravenous or 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
336
Enrollment target

NCT00081484 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 336 participants.

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The verdict

NCT00081484, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
336 participants
Enrollment target

Study Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Interventions

  • DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
  • DRUG epoetin alfa or beta

Trial Details

FieldValue
Enrollment Target 336 participants
Start Date 2004-06
Est. Completion 2006-03
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT00081484

The ClinicalTrials.gov registry entry for NCT00081484 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which methoxy polyethylene glycol-epoetin beta [Mircera] is the first listed.

NCT00081484 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00081484 about?

NCT00081484 is a clinical study titled "A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients". This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on stu...

What is the current status of trial NCT00081484?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2004-06. Estimated completion is 2006-03.

What interventions are being tested in trial NCT00081484?

The interventions under investigation include: methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG), epoetin alfa or beta (DRUG).

Who is sponsoring clinical trial NCT00081484?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.