Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia, Kidney Disease, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hemo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2015
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01519947
Start Date
May 30 2012
End Date
May 30 2015
Last Update
June 19 2019
Active Locations (7)
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1
Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
Aguascalientes, Mexico, 20210
2
Nefros Investigación S.C.
Delegación Coyoacan, Mexico, CP. 04700
3
Centro de hemodialisis del norte S.C.
Mexicali, Mexico, 21100
4
Hospital Angeles Lindavista;Nefrologia
Mexico City, Mexico, 07760