A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

June 15, 2017 updated by: Hoffmann-La Roche

Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)

This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Arta, Greece, 47100
        • General Hospital of Artas; Nephrology
      • Athens, Greece, 10433
        • Pantokrator Private Clinic; Nephrology
      • Athens, Greece, 11362
        • Attikon Center; Nephrology
      • Athens, Greece, 11521
        • Athinaiki Private Clinic
      • Athens, Greece, 11528
        • Kyanos Stavros Private Hospital; Nephrologic Clinic
      • Athens, Greece, 15562
        • Iaso General Private Clinic; Nephrology
      • Daphni-athens, Greece, 17237
        • Iatriko Athinon Clinic Dafnis; Nephrology Department
      • Egaleo, Greece, 12244
        • Timios Stavros Clinic; Nephrology Department
      • Patra, Greece, 26225
        • Kyanous Stavros of Patras, Renal Disease Therapy Unit
      • Patra, Greece, 26443
        • Olympion Therapeytirion; Nefrology
      • Pireus, Greece, 42356
        • Iasis Private Clinic
      • Polygyros, Greece, 63100
        • General Hospital Of Chalkidikis; Dialysis Center Unit
      • Thessaloniki, Greece, 57001
        • Diavalkaniko Kentro; Nephrology
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessalonikis G.Papanikolaou; Nephrology
      • Thessaloniki, Greece, 57500
        • Alfa Nefrodynamiki; Nefrology
      • Volos, Greece, 38221
        • Thessaliki Nossileytiki; Nephrology
      • Volos, Greece, 38222
        • General Hospital of Volos; Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with renal anemia on treatment with Mircera

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Renal anemia treated with Mircera for at least 6 months before entering study

Exclusion Criteria:

  • Patients who refuse or are incapable of giving their written informed consent to retrospective data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
Time Frame: Up to 6 months
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
Time Frame: Up to 6 months
Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2009

Primary Completion (Actual)

February 28, 2011

Study Completion (Actual)

February 28, 2011

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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