A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving 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: NCT00211068 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : April 30, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Pure Red-cell Aplasia | Drug: No intervention |
Study Type : | Observational |
Actual Enrollment : | 124 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official 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 |
Study Start Date : | March 2004 |
Actual Study Completion Date : | March 2006 |

Group/Cohort | Intervention/treatment |
---|---|
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.
|
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 |
- 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.
- Study medication-related risk factors: Number of participants who received HSA-free drug [ Time Frame: 1 year prior to the reference date ]
- Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously [ Time Frame: 1 year prior to the reference date ]
- Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously [ Time Frame: 1 year prior to the reference date ]
- Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa [ Time Frame: 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 [ Time Frame: 1 year prior to the reference date ]
- 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 ]
- 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 ]
- Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa [ Time Frame: 1 year prior to the reference date ]
- Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs [ Time Frame: 1 year prior to the reference date ]
- Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing [ Time Frame: 6 months prior to the reference date ]
- 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 ]
- Participant-related risk factors: Number of participants according to age [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants according to sex [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants according to race [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease [ Time Frame: 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) [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with history of malnutrition [ Time Frame: 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 [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with history of immune dysregulation [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with uncontrolled hypothyroidism [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with history of malignancy [ Time Frame: 5 years prior to the reference date ]
- Participant-related risk factors: Number of participants with history of viral infection [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with history of vaccination [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with history of frequent transfusions [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with treatment with other subcutaneous medications [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants with treatment with other recombinant human proteins [ Time Frame: 1 year prior to the reference date ]
- Participant-related risk factors: Number of participants who received other concomitant therapy [ Time Frame: 1 year prior to the reference date ]
- 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.
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT00211068
Brazil | |
Sao Paulo, Brazil | |
Sorocaba, Brazil | |
France | |
Bois Guillaume Cedex, France | |
Grenoble Cedex 1, France | |
Nantes Cedex 2, France | |
Orleans Cedex 2, France | |
Paris Cedex 20, France | |
Norway | |
Tvnsberg, Norway | |
South Africa | |
Bloemfontein, South Africa | |
Sweden | |
Karlshamn, Sweden | |
Stockholm N/A, Sweden | |
Trollhättan, Sweden | |
Thailand | |
Vlissingen, Thailand | |
United Kingdom | |
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 |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00211068 |
Other Study ID Numbers: |
CR004408 EPO-IMU-403 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ) |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | April 30, 2013 |
Last Verified: | April 2013 |
Pure red-cell aplasia Chronic kidney failure Epoetin alfa (Eprex) |
Erythropoietin Kidney disease Anemia |
Kidney Diseases Renal Insufficiency, Chronic Red-Cell Aplasia, Pure Urologic Diseases |
Renal Insufficiency Anemia Hematologic Diseases |