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

Completed

• Conditions: Anemia, Kidney Disease, Chronic

• Registration Number: NCT01379963
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Primary Completion: 2011-02-28
• Study Completion: 2011-02-28
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Results First Submitted: 2015-11-20
• Results First Submitted QC: 2015-11-20
• Results First Posted: 2015-12-24
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)	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

Name	Time	Method
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL	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.

Trial Locations

Locations (17)

General Hospital of Artas; Nephrology; 🇬🇷 Arta, Greece

Pantokrator Private Clinic; Nephrology; 🇬🇷 Athens, Greece

Attikon Center; Nephrology; 🇬🇷 Athens, Greece

Athinaiki Private Clinic; 🇬🇷 Athens, Greece

Kyanos Stavros Private Hospital; Nephrologic Clinic; 🇬🇷 Athens, Greece

Iaso General Private Clinic; Nephrology; 🇬🇷 Athens, Greece

Iatriko Athinon Clinic Dafnis; Nephrology Department; 🇬🇷 Daphni-athens, Greece

Timios Stavros Clinic; Nephrology Department; 🇬🇷 Egaleo, Greece

Kyanous Stavros of Patras, Renal Disease Therapy Unit; 🇬🇷 Patra, Greece

Olympion Therapeytirion; Nefrology; 🇬🇷 Patra, Greece

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