Clinical trial NCT01940484: An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
timeFrame: Visit 2 (Month 1)
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
timeFrame: Visit 3 (Month 2)
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
timeFrame: Visit 4 (Month 3)
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
timeFrame: Visit 5 (Month 4)
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
timeFrame: Visit 6 (Month 5)
measure: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
timeFrame: Visit 7 (Month 6)
measure: Mean Hemoglobin Value at Visit 2 (Month 1)
timeFrame: Visit 2 (Month 1)
measure: Mean Hemoglobin Value at Visit 3 (Month 2)
timeFrame: Visit 3 (Month 2)
measure: Mean Hemoglobin Value at Visit 4 (Month 3)
timeFrame: Visit 4 (Month 3)
measure: Mean Hemoglobin Value at Visit 5 (Month 4)
timeFrame: Visit 5 (Month 4)
measure: Mean Hemoglobin Value at Visit 6 (Month 5)
timeFrame: Visit 6 (Month 5)
measure: Mean Hemoglobin Value at Visit 7 (Month 6)
timeFrame: Visit 7 (Month 6)
Secondary outcomes:
measure: Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
timeFrame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)
measure: Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
timeFrame: 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)
measure: 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
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Benoni
country: South Africa
facility: Glynnwood Hospital
city: Bloemfontein
country: South Africa
facility: Universitas Private Hospital
city: Cape Town
country: South Africa
facility: GVI Constantiaberg
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital; Renal Unit
city: Cape Town
country: South Africa
facility: N1City Hospital
city: Durban
country: South Africa
facility: Dr KB Parag & Raghubir Kidney and Dialysis Centre
city: Durban
country: South Africa
facility: St Augustine Hospital / Chelmsford Medical Center; Nephrology
city: Johannesburg
country: South Africa
facility: Mayo Clinic
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Johannesburg
country: South Africa
facility: Donald Gordon Medical Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: