Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
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|ClinicalTrials.gov Identifier: NCT02648126|
Recruitment Status : Unknown
Verified January 2016 by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz).
Recruitment status was: Enrolling by invitation
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Red-Cell Aplasia, Pure Renal Insufficiency, Chronic||Procedure: Pure Red Cell Aplasia diagnostic confirmation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||531 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Research of Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa Produced by Immunobiological Technology Institute (Bio-Manguinhos) From Oswaldo Cruz Foundation (Bio-Manguinhos / Fiocruz)|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Pure red cell aplasia participants
Group of participants with pure red cell aplasia and chronic kidney disease, that have resistance criteria to treatment with epoetin alfa produced by Bio-Manguinhos / Fiocruz. The Patients who meet the appropriate criteria in the selection period will be subject to Pure Red Cell Aplasia diagnostic confirmation.
Procedure: Pure Red Cell Aplasia diagnostic confirmation
Patients who meet the appropriate criteria in the selection period will be subject to Pure Red Cell Aplasia diagnostic confirmation by collecting 20 mL of blood in dialysis units.
The samples will be processed, aliquoted and transported to Bio-Manguinhos, where depart periodically (according to the volume of samples) to the reference laboratory Sce Immunologie et d'Hématologie biologiques Hôpital Saint Antoine, where the dosage of antibody will be held anti epoetin alfa
- Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies. [ Time Frame: 3 years ]
- Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies [ Time Frame: 3 years ]
- Anti-alfa epoetin antibodies titers related to Hemoglobin levels [ Time Frame: 3 years ]
- Hemoglobin levels related to alfa epoetin dosage [ Time Frame: 3 years ]
- Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648126
|Principal Investigator:||Vivian Rotman, M.D.||Biomanguinhos|