| Trial ID: | L1559 |
| Source ID: | NCT01184495
|
| Associated Drug: |
Epoetin Alfa-Biomanguinhos
|
| Title: |
Efficacy Study of Two Formulations of Erythropoietin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
|
| Interventions: |
DRUG: Epoetin Alfa-BioManguinhos|DRUG: Epoetin Alfa-BioSimilar
|
| Outcome Measures: |
Primary: Hemoglobin Level in blood, The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months)., Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months | Secondary: Safety, Assessing the safety of the formulation produced by Bio-Manguinhos was performed by comparing the rate of adverse events related to the use of recombinant EPO in the two study groups, Monthly assessment of adverse events
|
| Sponsor/Collaborators: |
Sponsor: Hospital de Clinicas de Porto Alegre | Collaborators: Rio Grande do Sul State Health Department - SES/RS|Oswaldo Cruz Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2009-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-27
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01184495
|
