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

An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

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 Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Methoxy polyethylene glycol epoetin beta

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• South Africa
  • Benoni, South Africa, 1501
    • Glynnwood Hospital
  • Bloemfontein, South Africa, 9301
    • Universitas Private Hospital
  • Cape Town, South Africa, 7800
    • GVI Constantiaberg
  • Cape Town, South Africa, 7925
    • Groote Schuur Hospital; Renal Unit
  • Cape Town, South Africa, 7925
    • N1City Hospital
  • Durban, South Africa, 4001
    • Dr KB Parag & Raghubir Kidney and Dialysis Centre
  • Durban, South Africa
    • St Augustine Hospital / Chelmsford Medical Center; Nephrology
  • Johannesburg, South Africa, 2193
    • Donald Gordon Medical Centre
  • Johannesburg, South Africa, 2157
    • Sunninghill Hospital
  • Johannesburg, South Africa, 1724
    • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Renal Anemia Participants; 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.	Drug: Methoxy polyethylene glycol epoetin beta; Other Names: Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta	Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.	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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2009
• Primary Completion (Actual): July 31, 2012
• Study Completion (Actual): July 31, 2012

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML22344