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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 6, 2016
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa
Official Title  ICMJE 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)
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Red-Cell Aplasia, Pure
  • Renal Insufficiency, Chronic
Intervention  ICMJE 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

Study Arms  ICMJE 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.
Intervention: Procedure: Pure Red Cell Aplasia diagnostic confirmation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2016)
531
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02648126
Other Study ID Numbers  ICMJE ASCLIN 004/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Sponsor  ICMJE The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vivian Rotman, M.D. Biomanguinhos
PRS Account The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP