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COMPLETED Phase 3

A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

NCT00081471 · View on ClinicalTrials.gov ↗

Study Summary

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Conditions Studied

Interventions

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

Study Locations (20)

California

  • — Los Angeles
  • — Mather
  • — Stanford

Texas

  • — Austin
  • — Dallas
  • — Houston

Florida

  • — Bay Pines
  • — Ocala

Massachusetts

  • — Boston
  • — Boston

Connecticut

  • — Stamford

Louisiana

  • — Shreveport

Michigan

  • — Detroit

New York

  • — Flushing

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2004-06
Est. Completion 2006-07
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00081471

The ClinicalTrials.gov registry entry for NCT00081471 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions — of which darbepoetin alfa is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00081471 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00081471 about?

NCT00081471 is a clinical study titled "A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis". This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target...

What is the current status of trial NCT00081471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2004-06. Estimated completion is 2006-07.

What conditions does trial NCT00081471 study?

This clinical trial studies the following conditions: Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00081471?

The interventions under investigation include: darbepoetin alfa (DRUG), methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00081471?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00081471 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial