NCT02648126

Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 531 (estimated)
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Red-Cell Aplasia, Pure
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2016-01-06
• Last updated: 2016-01-06