Trial record 2 of 22 for:    "Pure red cell aplasia"

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
  Purpose

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).


Condition Intervention Phase
Pure Red-cell Aplasia
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Blood sample collected for pharmacogenomic analysis


Enrollment: 124
Study Start Date: March 2004
Study Completion Date: March 2006
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211068

Locations
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
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00211068     History of Changes
Other Study ID Numbers: CR004408, EPO-IMU-403
Study First Received: September 13, 2005
Last Updated: April 29, 2013
Health Authority: Norway: Directorate of Health

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Pure red-cell aplasia
Chronic kidney failure
Epoetin alfa (Eprex)
Erythropoietin
Kidney disease
Anemia

Additional relevant MeSH terms:
Kidney Diseases
Red-Cell Aplasia, Pure
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Anemia
Hematologic Diseases
Renal Insufficiency
Antibodies
Epoetin Alfa
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014