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

• Status: Completed
• Trial end date: 2015-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

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