An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

N/ACompletedNCT01940484

Hoffmann-La Roche98 enrolled

Overview

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anemia

Interventions

Methoxy polyethylene glycol epoetin betaDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL) * Participants had to be receiving an ESA prior to entering the study * Female participants of childbearing age had to be using effective contraceptive methods Exclusion Criteria: * As per approved package insert * Any contraindication to ESA treatment

Locations (10)

Glynnwood Hospital

Benoni, South Africa

Universitas Private Hospital

Bloemfontein, South Africa

GVI Constantiaberg

Cape Town, South Africa

Groote Schuur Hospital; Renal Unit

Cape Town, South Africa

N1City Hospital

Cape Town, South Africa

Dr KB Parag & Raghubir Kidney and Dialysis Centre

Durban, South Africa

St Augustine Hospital / Chelmsford Medical Center; Nephrology

Durban, South Africa

Mayo Clinic

Johannesburg, South Africa

Sunninghill Hospital

Johannesburg, South Africa

Donald Gordon Medical Centre

Johannesburg, South Africa

Outcomes

Primary Outcomes

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)

Time frame: Visit 2 (Month 1)

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)

Time frame: Visit 3 (Month 2)

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)

Time frame: Visit 4 (Month 3)

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)

Time frame: Visit 5 (Month 4)

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)

Time frame: Visit 6 (Month 5)

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)

Time frame: Visit 7 (Month 6)

Mean Hemoglobin Value at Visit 2 (Month 1)

Time frame: Visit 2 (Month 1)

Mean Hemoglobin Value at Visit 3 (Month 2)

Time frame: Visit 3 (Month 2)

Mean Hemoglobin Value at Visit 4 (Month 3)

Time frame: Visit 4 (Month 3)

Mean Hemoglobin Value at Visit 5 (Month 4)

Time frame: Visit 5 (Month 4)

Mean Hemoglobin Value at Visit 6 (Month 5)

Time frame: Visit 6 (Month 5)

Mean Hemoglobin Value at Visit 7 (Month 6)

Time frame: Visit 7 (Month 6)

Secondary Outcomes

Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study

Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)

Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta

Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.

Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)

Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert

Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.

Time frame: Up to 6 months