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 — ALTITUD  

Anemia, Kidney Disease, Chronic Clinical Trial

Official title: Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anemia
• Anemia, Kidney Disease, Chronic
• Chronic Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT01519947
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2012
• Completion date: May 30, 2015