| Trial ID: | L0408 |
| Source ID: | NCT01695759
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| Associated Drug: |
Epoetin Alpha
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| Title: |
Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Chronic Kidney Disease|Anemia
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| Interventions: |
DRUG: Epoetin alpha|DRUG: Eprex
|
| Outcome Measures: |
Primary: Change of hemoglobin levels at correction phase (baseline vs end of treatment), In the correction phase, change in serum Hb levels (baseline vs. end of initial treatment (EOIT) = levels of Hb presented before the V0 treatment compared to the Hb levels presented at the end of the correction phase) will be evaluated for a maximum period of 6 months after starting treatment. This one parameter will be demonstrated through: Percentage of participants achieving Hb levels within the target (≥ 10.5 to ≤ 12 g / dL)., until 6 months | Secondary: Maintenance of hemoglobin levels, Will be evaluated by porcentage of participants whose Hb levels remained within the therapeutic range (≥10,5 a ≤ 12 g/dL)., until the end of 12 months|Adjustment of EPO dose required during correction and/or maintenance phase, Will be evaluated by mean dose of EPO used between groups and number of participants that needed of dose adjustment over correction and/or maintenance phase., until the end of 12 months|Transfusion needs, Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study., until the end of 12 months|Report of Adverse Events, Will be evaluated by report of adverse events throughout the study. The Adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the investigational product., until the end of 12 months | Other: Immunological Response, The immunological response induced by epoetin alpha will be evaluated by quantification of anti-erithropoetin antibodies, every six months., every six months
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| Sponsor/Collaborators: |
Sponsor: Azidus Brasil | Collaborators: Blau Farmaceutica S.A.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
92
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2013-12
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| Completion Date: |
2018-01
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| Results First Posted: |
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| Last Update Posted: |
2018-08-20
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| Locations: |
Clínica Senhor do Bomfim Ltda, Feira de Santana, Bahia, 44001-584, Brazil|Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia, Curitiba, Parana, Brazil|Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos, Caxias do Sul, Rio Grande Do Sul, 95070-561, Brazil|Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil|União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil|Fundação Pró-Rim, Joinville, Santa Catarina, Brazil|Hospital de Ensino Padre Anchieta, São Bernardo do Campo, São Paulo, Brazil|CMIN - Clínica De Medicina Interna E Nefrologia, São Paulo, 05001-000, Brazil|Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão), São Paulo, Brazil|Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa), São Paulo, Brazil
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| URL: |
https://clinicaltrials.gov/show/NCT01695759
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