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

Phase 4

Completed

• Conditions: Anemia, Kidney Disease, Chronic
• Interventions: Drug: Methoxy polyethylene glycol-epoetin beta

• Registration Number: NCT01519947
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-27
• Study Start: 2012-05-30
• Primary Completion: 2015-05-30
• Study Completion: 2015-05-30
• Results First Submitted: 2017-09-08
• Results First Submitted QC: 2018-06-13
• Results First Posted: 2018-12-27
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialysis, sea level	Methoxy polyethylene glycol-epoetin beta	Participants received 50-250 mcg SC according to local label.
Pre-dialysis, sea level	Methoxy polyethylene glycol-epoetin beta	Participants received 50-250 mcg SC according to local label.
Pre-dialysis, >1800 meters	Methoxy polyethylene glycol-epoetin beta	Participants received 50-250 mcg SC according to local label.
Dialysis, >1800 meters	Methoxy polyethylene glycol-epoetin beta	Participants received 50-250 mcg SC according to local label.

Primary Outcome Measures

Name	Time	Method
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL	Up to approximately 20 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment	3 and 6 months
Percentage of Participants Requiring Dose Adjustments	Up to approximately 20 months	This outcome measure was not assessed.
Change in Hemoglobin Concentration	From baseline to 6 months
Percentage of Participants With Adverse Events	Up to approximately 20 months	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.
Incidence of Red Blood Cell Transfusions	Up to approximately 20 months	This outcome measure was not assessed.

Trial Locations

Locations (7)

Unidad De Dialisis La Loma S.C.; 🇲🇽 Pureto Vallarta, Mexico

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

Hospital Regional De Alta Especialidad De Veracruz; Nephrology; 🇲🇽 Veracruz, Mexico