A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)
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)
1 other identifier
observational
780
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2011
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedResults Posted
Study results publicly available
December 24, 2015
CompletedJuly 13, 2017
May 1, 2017
1.8 years
June 22, 2011
November 20, 2015
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
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 Outcomes (1)
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
Up to 6 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with renal anemia on treatment with Mircera
You may qualify if:
- Adult patients, \>/= 18 years of age
- Renal anemia treated with Mircera for at least 6 months before entering study
You may not qualify if:
- Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Timios Stavros Clinic; Nephrology Department
Aigáleo, 12244, Greece
General Hospital of Artas; Nephrology
Arta, 47100, Greece
Pantokrator Private Clinic; Nephrology
Athens, 10433, Greece
Attikon Center; Nephrology
Athens, 11362, Greece
Athinaiki Private Clinic
Athens, 11521, Greece
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, 11528, Greece
Iaso General Private Clinic; Nephrology
Athens, 15562, Greece
Iatriko Athinon Clinic Dafnis; Nephrology Department
Daphni-athens, 17237, Greece
Kyanous Stavros of Patras, Renal Disease Therapy Unit
Pátrai, 26225, Greece
Olympion Therapeytirion; Nefrology
Pátrai, 26443, Greece
Iasis Private Clinic
Piraeus, 42356, Greece
General Hospital Of Chalkidikis; Dialysis Center Unit
Polygyros, 63100, Greece
Diavalkaniko Kentro; Nephrology
Thessaloniki, 57001, Greece
General Hospital of Thessalonikis G.Papanikolaou; Nephrology
Thessaloniki, 57010, Greece
Alfa Nefrodynamiki; Nefrology
Thessaloniki, 57500, Greece
Thessaliki Nossileytiki; Nephrology
Volos, 38221, Greece
General Hospital of Volos; Nephrology
Volos, 38222, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2011
First Posted
June 23, 2011
Study Start
April 30, 2009
Primary Completion
February 28, 2011
Study Completion
February 28, 2011
Last Updated
July 13, 2017
Results First Posted
December 24, 2015
Record last verified: 2017-05