| Trial ID: | L1676 |
| Source ID: | NCT00211068
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| Associated Drug: |
No Intervention
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| Title: |
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Pure Red-cell Aplasia
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| Interventions: |
DRUG: No intervention
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| Outcome Measures: |
Primary: Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug, 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., 1 year prior to the reference date|Study medication-related risk factors: Number of participants who received HSA-free drug, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs, 1 year prior to the reference date|Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing, 6 months prior to the reference date|Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing, 6 months prior to the reference date|Participant-related risk factors: Number of participants according to age, 1 year prior to the reference date|Participant-related risk factors: Number of participants according to sex, 1 year prior to the reference date|Participant-related risk factors: Number of participants according to race, 1 year prior to the reference date|Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease, 1 year prior to the reference date|Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date), 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of malnutrition, 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing, 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of immune dysregulation, 1 year prior to the reference date|Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism, 1 year prior to the reference date|Participant-related risk factors: Number of participants with uncontrolled hypothyroidism, 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of malignancy, 5 years prior to the reference date|Participant-related risk factors: Number of participants with history of viral infection, 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of vaccination, 1 year prior to the reference date|Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy, 1 year prior to the reference date|Participant-related risk factors: Number of participants with history of frequent transfusions, 1 year prior to the reference date|Participant-related risk factors: Number of participants with treatment with other subcutaneous medications, 1 year prior to the reference date|Participant-related risk factors: Number of participants with treatment with other recombinant human proteins, 1 year prior to the reference date|Participant-related risk factors: Number of participants who received other concomitant therapy, 1 year prior to the reference date | Secondary: Human leukocyte antigen (HLA) typing, 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., 1 year prior to the reference date
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| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
124
|
| Study Type: |
OBSERVATIONAL
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| Study Designs: |
Observational Model: |Time Perspective: p
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| Start Date: |
2004-03
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| Completion Date: |
2006-03
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| Results First Posted: |
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| Last Update Posted: |
2013-04-30
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| Locations: |
Sao Paulo, Brazil|Sorocaba, Brazil|Bois Guillaume Cedex, France|Grenoble Cedex 1, France|Nantes Cedex 2, France|Orleans Cedex 2, France|Paris Cedex 20, France|Tvnsberg, Norway|Bloemfontein, South Africa|Karlshamn, Sweden|Stockholm N/A, Sweden|Trollhättan, Sweden|Vlissingen, Thailand|Birmingham, United Kingdom|Brighton, United Kingdom|Bristol, United Kingdom|Chelmsford, United Kingdom|Edinburgh, United Kingdom|London, United Kingdom|Manchester, United Kingdom|Omagh N/A, United Kingdom|Westcliff-On-Sea, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT00211068
|
