This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Participants received 50-250 mcg SC according to local label
Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
Aguascalientes, Mexico
Nefros Investigación S.C.
Delegación Coyoacan, Mexico
Centro de hemodialisis del norte S.C.
Mexicali, Mexico
Hospital Angeles Lindavista;Nefrologia
Mexico City, Mexico
Hospital Star Medica Morelia
Morelia, Mexico
Unidad De Dialisis La Loma S.C.
Pureto Vallarta, Mexico
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Veracruz, Mexico
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
Time frame: Up to approximately 20 months
Change in Hemoglobin Concentration
Time frame: From baseline to 6 months
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
Time frame: 3 and 6 months
Percentage of Participants With Adverse Events
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Time frame: Up to approximately 20 months
Percentage of Participants Requiring Dose Adjustments
This outcome measure was not assessed.
Time frame: Up to approximately 20 months
Incidence of Red Blood Cell Transfusions
This outcome measure was not assessed.
Time frame: Up to approximately 20 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.