Clinical Trial: Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
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) Fro
Brief Summary: The purpose of this study is to determine occurrence of pure red cell aplasia in a group of participants with chronic renal insufficiency and with resistance criteria to epoetin alfa treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and it is provided by the Unified Health System.
Detailed Summary:
Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Current Primary Outcome: Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies. [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Dates:
Date Received: January 5, 2016
Date Started: November 2015
Date Completion: December 2017
Last Updated: January 5, 2016
Last Verified: January 2016
