Back to resultsPure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
Primary Purpose
Red-Cell Aplasia, Pure, Renal Insufficiency, Chronic
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pure Red Cell Aplasia diagnostic confirmation
Sponsored by
About this trial
This is an interventional diagnostic trial for Red-Cell Aplasia, Pure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pure red cell aplasia participants
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies.
Secondary Outcome Measures
Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies
Anti-alfa epoetin antibodies titers related to Hemoglobin levels
Hemoglobin levels related to alfa epoetin dosage
Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels
Full Information
NCT ID
NCT02648126
First Posted
January 5, 2016
Last Updated
January 5, 2016
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
1. Study Identification
Unique Protocol Identification Number
NCT02648126
Brief Title
Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Red-Cell Aplasia, Pure, Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
531 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pure red cell aplasia participants
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pure Red Cell Aplasia diagnostic confirmation
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies
Time Frame
3 years
Title
Anti-alfa epoetin antibodies titers related to Hemoglobin levels
Time Frame
3 years
Title
Hemoglobin levels related to alfa epoetin dosage
Time Frame
3 years
Title
Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Rotman, M.D.
Organizational Affiliation
Biomanguinhos
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
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