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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00211068
First received: September 13, 2005
Last updated: April 29, 2013
Last verified: April 2013

September 13, 2005
April 29, 2013
March 2004
Not Provided
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Study medication-related risk factors: Number of participants who received HSA-free drug [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing [ Time Frame: 6 months prior to the reference date ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants according to age [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants according to sex [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants according to race [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of malnutrition [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of immune dysregulation [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with uncontrolled hypothyroidism [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of malignancy [ Time Frame: 5 years prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of viral infection [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of vaccination [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with history of frequent transfusions [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with treatment with other subcutaneous medications [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants with treatment with other recombinant human proteins [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
  • Participant-related risk factors: Number of participants who received other concomitant therapy [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00211068 on ClinicalTrials.gov Archive Site
Human leukocyte antigen (HLA) typing [ Time Frame: 1 year prior to the reference date ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
Not Provided
 
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
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

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).

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample collected for pharmacogenomic analysis

Non-Probability Sample

Participants having chronic kidney disease and an immune-mediated cause of pure red cell aplasia indicated by the presence of anti-erythropoietin antibodies in their serum at the time of loss of efficacy

Pure Red-cell Aplasia
Drug: No intervention
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 Name: EPREX
Epoetin alfa
Four control patients will be matched to each index patients enrolled in protocol EPO-IMU-301 identified as having chronic kidney disease and an immune-mediated cause of pure red cell aplasia (PRCA) indicated by the presence of anti-erythropoietin (EPO) antibodies in their serum at the time of loss of efficacy.
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
March 2006
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Brazil,   France,   Norway,   South Africa,   Sweden,   Thailand
 
NCT00211068
CR004408, EPO-IMU-403
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2013

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