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Completed

NCT Number: NCT00211068

A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

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Key information

Conditions

Pure Red-Cell Aplasia Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Red-Cell Aplasia, Pure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sorocaba, Brazil

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About this study

This is a multicenter (study conducted at multiple sites), case-control (study that compare individuals with a disease or condition [cases] to a group of individuals without the disease or condition [controls] to determine the possible factor which increased disease incidence), retrospective (a study in which the participants are identified and then followed backward, as time passes) study. Retrospective risk factor data will be collected for control participants matched to the subset of participants in Protocol EPO-IMU-301 identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began while the participant was receiving treatment with EPREX (index participants). For each index participant, up to 4 matched non-PRCA control participants with chronic kidney disease will be enrolled in this study. Approximately 600 control participants will be enrolled in this study. Control participants will be selected from the same site as the index participant and the data will be collected from the date closest to the reference date (loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first seen) that the control participant satisfies all study inclusion and exclusion criteria. The optional pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin gene) will be recorded for the control participants who will sign the pharmacogenomics part of the study. No drug administration or treatment will be mandated by this study. Safety evaluation will include assessment of adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of anemia due to chronic kidney disease
  • Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment
  • Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first observed)

Exclusion criteria

  • History of and information related to past exposure to EPO not available
  • History of PRCA or anti-EPO antibody positive status before or after the reference date

Treatment and study plan

No intervention

Drug

This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.

Other names: EPREX

Primary outcomes

  1. Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug

    Time frame: 1 year prior to the reference date

    The reference date is the day on which Loss of Efficacy (LOE) was first suspected, where LOE is the date that a drop in hemoglobin of greater than 2 g/dL/month was first seen.

  2. Study medication-related risk factors: Number of participants who received HSA-free drug

    Time frame: 1 year prior to the reference date

  3. Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously

    Time frame: 1 year prior to the reference date

  4. Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously

    Time frame: 1 year prior to the reference date

  5. Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa

    Time frame: 1 year prior to the reference date

  6. Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic

    Time frame: 1 year prior to the reference date

  7. Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment

    Time frame: 1 year prior to the reference date

  8. Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment

    Time frame: 1 year prior to the reference date

  9. Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa

    Time frame: 1 year prior to the reference date

  10. Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs

    Time frame: 1 year prior to the reference date

  11. Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing

    Time frame: 6 months prior to the reference date

  12. Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing

    Time frame: 6 months prior to the reference date

  13. Participant-related risk factors: Number of participants according to age

    Time frame: 1 year prior to the reference date

  14. Participant-related risk factors: Number of participants according to sex

    Time frame: 1 year prior to the reference date

  15. Participant-related risk factors: Number of participants according to race

    Time frame: 1 year prior to the reference date

  16. Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease

    Time frame: 1 year prior to the reference date

  17. Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)

    Time frame: 1 year prior to the reference date

  18. Participant-related risk factors: Number of participants with history of malnutrition

    Time frame: 1 year prior to the reference date

  19. Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing

    Time frame: 1 year prior to the reference date

  20. Participant-related risk factors: Number of participants with history of immune dysregulation

    Time frame: 1 year prior to the reference date

  21. Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism

    Time frame: 1 year prior to the reference date

  22. Participant-related risk factors: Number of participants with uncontrolled hypothyroidism

    Time frame: 1 year prior to the reference date

  23. Participant-related risk factors: Number of participants with history of malignancy

    Time frame: 5 years prior to the reference date

  24. Participant-related risk factors: Number of participants with history of viral infection

    Time frame: 1 year prior to the reference date

  25. Participant-related risk factors: Number of participants with history of vaccination

    Time frame: 1 year prior to the reference date

  26. Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy

    Time frame: 1 year prior to the reference date

  27. Participant-related risk factors: Number of participants with history of frequent transfusions

    Time frame: 1 year prior to the reference date

  28. Participant-related risk factors: Number of participants with treatment with other subcutaneous medications

    Time frame: 1 year prior to the reference date

  29. Participant-related risk factors: Number of participants with treatment with other recombinant human proteins

    Time frame: 1 year prior to the reference date

  30. Participant-related risk factors: Number of participants who received other concomitant therapy

    Time frame: 1 year prior to the reference date

Secondary outcomes

  1. Human leukocyte antigen (HLA) typing

    Time frame: 1 year prior to the reference date

    The optional pharmacogenomic (use of genetic information to predict whether the study medication will help make a patient well or ill) part of the study will test for polymorphisms and haploid types of the erythropoietin gene. HLA typing will be recorded for the control participants who will sign the pharmacogenomics part of the study.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Registry information

Official study title

Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

Important dates

Study start
2004
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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