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

Completed

• Conditions: Anemia
• Interventions: Drug: Methoxy polyethylene glycol epoetin beta

• Registration Number: NCT01940484
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-31
• Primary Completion: 2012-07-31
• Study Completion: 2012-07-31
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Results First Submitted: 2016-03-21
• Results First Submitted QC: 2016-03-21
• Results First Posted: 2016-04-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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Exclusion Criteria

• As per approved package insert
• Any contraindication to ESA treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Renal Anemia Participants	Methoxy polyethylene glycol epoetin beta	Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)	Visit 2 (Month 1)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)	Visit 3 (Month 2)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)	Visit 4 (Month 3)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)	Visit 5 (Month 4)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)	Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)	Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 2 (Month 1)	Visit 2 (Month 1)
Mean Hemoglobin Value at Visit 3 (Month 2)	Visit 3 (Month 2)
Mean Hemoglobin Value at Visit 4 (Month 3)	Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 5 (Month 4)	Visit 5 (Month 4)
Mean Hemoglobin Value at Visit 6 (Month 5)	Visit 6 (Month 5)
Mean Hemoglobin Value at Visit 7 (Month 6)	Visit 7 (Month 6)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta	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)	Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study	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 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	Up to 6 months	Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.

Trial Locations

Locations (10)

Donald Gordon Medical Centre; 🇿🇦 Johannesburg, South Africa

Universitas Private Hospital; 🇿🇦 Bloemfontein, South Africa

Glynnwood Hospital; 🇿🇦 Benoni, South Africa

Groote Schuur Hospital; Renal Unit; 🇿🇦 Cape Town, South Africa

Dr KB Parag & Raghubir Kidney and Dialysis Centre; 🇿🇦 Durban, South Africa

GVI Constantiaberg; 🇿🇦 Cape Town, South Africa

St Augustine Hospital / Chelmsford Medical Center; Nephrology; 🇿🇦 Durban, South Africa

Mayo Clinic; 🇿🇦 Johannesburg, South Africa

Sunninghill Hospital; 🇿🇦 Johannesburg, South Africa

N1City Hospital; 🇿🇦 Cape Town, South Africa