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New monthly shot could simplify anemia treatment for kidney patients

NCT ID NCT00560404

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a once-monthly injection of Mircera works as well as the standard epoetin alfa treatment for managing anemia in people on dialysis. About 233 adults with chronic kidney disease-related anemia participated. The goal was to see if Mircera could keep hemoglobin levels stable within a healthy range, offering a more convenient dosing schedule.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mircera (methoxy polyethylene glycol-epoetin beta)
What this could lead to
If successful, this could offer dialysis patients a more convenient once-monthly injection option to manage anemia, reducing the need for more frequent dosing.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. The main risk is that Mircera may not control hemoglobin as effectively as standard treatment, potentially leading to anemia-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

233 people

The number who actually took part.

Start date

Apr 2008

Finished

Dec 2010

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * regular hemodialysis with the same schedule of dialysis for \>=12 weeks; * maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks. Exclusion Criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months; * acute or chronic bleeding; * active malignant disease (except non-melanoma skin cancer).

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

Contacts and locations

Locations

  • Study site

    Belo Horizonte, 30150-320, Brazil

  • Study site

    Brasília, 70390-108, Brazil

  • Study site

    Campinas, 13086-970, Brazil

  • Study site

    Campo Grande, 79002-073, Brazil

  • Study site

    Cariacica, 29152-230, Brazil

  • Study site

    Curitiba, 80050-350, Brazil

  • Study site

    Curitiba, 80440-020, Brazil

  • Study site

    Fortaleza, 60430160, Brazil

  • Study site

    Jaboatão dos Guararapes, 54400-170, Brazil

  • Study site

    Joinville, 89227-680, Brazil

  • Study site

    Juiz de Fora, 36036900, Brazil

  • Study site

    Londrina, 86015-000, Brazil

  • Study site

    Natal, 59020-110, Brazil

  • Study site

    Porto Alegre, 90035-903, Brazil

  • Study site

    Porto Alegre, 90610000, Brazil

  • Study site

    Ribeirão Preto, 14025-170, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    Salvador, 40110-060, Brazil

  • Study site

    São José do Rio Preto, 15090-000, Brazil

  • Study site

    São Luís, 65020-305, Brazil

  • Study site

    São Paulo, 01246-903, Brazil

  • Study site

    São Paulo, 01323-900, Brazil

  • Study site

    São Paulo, 01532-001, Brazil

  • Study site

    São Paulo, 03065-000, Brazil

  • Study site

    São Paulo, O4023, Brazil

  • Study site

    Sorocaba, 18030-210, Brazil

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