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

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ClinicalTrials.gov Identifier: NCT01379963
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : December 24, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease
Anemia, Kidney Disease, Chronic

Study Type : Observational
Actual Enrollment : 780 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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)
Actual Study Start Date : April 30, 2009
Actual Primary Completion Date : February 28, 2011
Actual Study Completion Date : February 28, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort
Cohort



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with renal anemia on treatment with Mircera
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379963


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01379963     History of Changes
Other Study ID Numbers: ML22014
First Posted: June 23, 2011    Key Record Dates
Results First Posted: December 24, 2015
Last Update Posted: July 13, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Chronic Disease
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency