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)

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia, Kidney Disease, Chronic

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519947

ML25754

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 4 patient groups

Pre-dialysis, sea level

Active Comparator group

Description:

Participants received 50-250 mcg SC according to local label.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta

Dialysis, sea level

Active Comparator group

Description:

Participants received 50-250 mcg SC according to local label.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta

Pre-dialysis, >1800 meters

Experimental group

Description:

Participants received 50-250 mcg SC according to local label.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta

Dialysis, >1800 meters

Experimental group

Description:

Participants received 50-250 mcg SC according to local label.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta