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

Renal Insufficiency, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02648126
• Other study ID #: ASCLIN 004/2014
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 5, 2016
• Last updated: January 5, 2016
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 531
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Use of alfa epoetin manufactured by Bio-Manguinhos for at least 8 weeks before the moment of hyporesponsiveness diagnosis;

• Nonuse of alfa epoetin from another manufacturer for at least 24 weeks before hyporesponsiveness diagnosis;

• Presence of the criteria for pure red cell aplasia disease, which is absence of a significant reduction in serum levels of leukocytes and platelets.

Exclusion Criteria:

The screened patients who have at least one of the following criteria will be excluded from the study, and it may be replaced by another participant for the research.

• if there is no legal representative, an intellectual disability that restrain the compliance and signature of informed consent,

• no agreement assigning the informed consent;

• It will be excluded from the study if from the moment of hyporesponsiveness diagnosis the participant have: lactation pregnancy, hypersensitivity or intolerance previously known for alfa epoetin or one of its components, intolerance or allergy to parenteral iron, acute hemorrhage, kidney transplantation, hemolysis defined as the presence of anemia associated with high levels of indirect bilirubin and lactate dehydrogenase , percentage of reticulocytes> 1.5% absolute reticulocyte> 75,000 / microliter.

• deficiency of folate and / or vitamin B12.

• pancytopenia.

• in use with medications known to cause anemia and / or pure red cell aplasia as:

Valproic Acid; Azathioprine; Chloramphenicol; Phenytoin; Isoniazid; Mycophenolate mofetil.

• presence of the following comorbidities: Diabetes mellitus; epilepsy; chronic viral hepatitis; secondary hyperparathyroidism uncontrolled; hypertension systolic; inflammation (acute or chronic); myelofibrosis; myelodysplasia; neoplasm and thalassemias;

• severe disease in the 24 weeks before the hyporesponsiveness diagnosis; including:

stroke, septic shock, thromboembolic events; acute myocardial infarction

• lack of information or damage to quality data that avoid disease classification as a case of hyporesponsiveness.

• Immunoglobulin M and Immunoglobulin M serology for Parvovirus B19, Epstein-Barr and Cytomegalovirus.

• serology for HIV in the last 12 months.

• established immunological disease.

• dosage of protein C-reactive titrated .

• presence of antinuclear antibody and rheumatoid factor.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies.		3 years	Yes
Secondary	Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies		3 years	Yes
Secondary	Anti-alfa epoetin antibodies titers related to Hemoglobin levels		3 years	Yes
Secondary	Hemoglobin levels related to alfa epoetin dosage		3 years	Yes
Secondary	Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels		3 years	Yes