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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
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

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.

Condition or disease Intervention/treatment Phase
Red-Cell Aplasia, Pure Renal Insufficiency, Chronic Procedure: Pure Red Cell Aplasia diagnostic confirmation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 531 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





Primary Outcome Measures :
  1. Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies [ Time Frame: 3 years ]
  2. Anti-alfa epoetin antibodies titers related to Hemoglobin levels [ Time Frame: 3 years ]
  3. Hemoglobin levels related to alfa epoetin dosage [ Time Frame: 3 years ]
  4. Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Investigators
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Principal Investigator: Vivian Rotman, M.D. Biomanguinhos
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Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT02648126    
Other Study ID Numbers: ASCLIN 004/2014
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Red-Cell Aplasia, Pure
Urologic Diseases
Anemia
Hematologic Diseases