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
NCT ID: NCT01519947
Last Updated: 2019-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
87 participants
INTERVENTIONAL
2012-05-30
2015-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pre-dialysis, sea level
Participants received 50-250 mcg SC according to local label.
Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Dialysis, sea level
Participants received 50-250 mcg SC according to local label.
Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Pre-dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Interventions
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Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Unidad De Dialisis La Loma S.C.
Pureto Vallarta, , Mexico
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Veracruz, , Mexico
Countries
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Other Identifiers
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ML25754
Identifier Type: -
Identifier Source: org_study_id
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