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A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

NCT01519947

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Anemia, Kidney Disease, Chronic

Interventions: Methoxy polyethylene glycol-epoetin beta

Countries: Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Chronic kidney disease stage III-IV or V
* Probable start of dialysis within 18 months (pre-dialysis group)
* Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
* Adequate iron status
* Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug

Exclusion Criteria:

* Failing renal allograft in place
* Acute or chronic bleeding within 8 weeks prior to screening
* Transfusion of red blood cells within 8 weeks prior to screening
* Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
* History of seizures, hemoglobinopathies and/or severe liver disease
* Active malignant disease, except for non-melanoma skin cancer
* Immunosuppressive therapy in the 12 weeks prior to screening
* Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
* Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
* Pregnant or lactating women

Locations (7)

Aguascalientes, Mexico
Delegación Coyoacan, Mexico
Mexicali, Mexico
Mexico City, Mexico
Morelia, Mexico
Pureto Vallarta, Mexico
Veracruz, Mexico