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Study to Monitor the Incidence of Pure Red Cell Aplasia (PRCA) and/or Antibodies to Erythropoietin Among Participants Receiving Epoetin Alfa or Another Erythropoietin

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ClinicalTrials.gov Identifier: NCT00210951
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA [suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production]) among participants with chronic renal failure (CRF), who were receiving treatment with epoetin alfa or other exogenous recombinant erythropoietin therapies.

Condition or disease Intervention/treatment Phase
Red-Cell Aplasia, Pure Chronic Renal Failure Other: No Intervention Phase 4

Detailed Description:
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) and cohort study. Study specific information will be collected from participants with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years and participants will not receive any intervention in this study. Upon entering the study, information will be collected regarding disease history and recombinant erythropoietin treatment. Every 3 months thereafter, progress information will be collected, including recombinant erythropoietin treatment, number of red blood cells and presence of any signs of pure red cell aplasia (PRCA) development. Blood samples will be collected at study entry and every 3 months. Participants discontinuing erythropoietin will be followed only for an additional 12 months from the time erythropoietin is discontinued. Participants will receive standard-of-care treatment for their chronic renal disease from their individual Investigators. Participants will be primarily observed prospectively for PRCA.

Study Design

Study Type : Observational
Actual Enrollment : 4761 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Active Safety Surveillance Plan to Conduct Serologic Testing for Anti-erythropoietin Antibodies and Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa or Another Erythropoietin
Study Start Date : May 2003
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Participants Receiving Epoetin Alfa or Another Erythropoietin
Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.
Other: No Intervention
Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Pure Red Cell Aplasia (PRCA) [ Time Frame: Up to 2 years ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.

  2. Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies [ Time Frame: Up to 2 years ]
    Antibodies are immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen (or a very similar shape) that induced their synthesis in cells of the lymphoid series.

  3. Relationship between EPO Antibodies and PRCA [ Time Frame: Up to 2 years ]
    Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.


Secondary Outcome Measures :
  1. Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration [ Time Frame: Every 3 Months up to up to 2 years ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.

  2. Change From Baseline in Number of Participants With PRCA Over Time [ Time Frame: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24 ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.

  3. Duration of Exposure [ Time Frame: Up to 2 years ]
    Duration of exposure to study medication is the time between the first and last dose of study medication.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.
Criteria

Inclusion Criteria:

  • Male or female participants of legal age to give consent according to local standards
  • Participants must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
  • Physicians treating the participants must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
  • If required by local ethics committees, participants must give consent to permit the collection of de-identified personal data for the specific purpose of this study and to collect blood samples for tests for antibodies to erythropoietin

Exclusion Criteria:

  • Participants who are unable to complete future follow-up visits
  • Participants who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
  • Participants with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
  • Participants whose anemia did not respond to previous treatment with an erythropoietin
  • Participants with a history of antibodies to erythropoietin prior to entering the study
Contacts and Locations

Information from the National Library of Medicine

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): NCT00210951


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

Additional Information:
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210951     History of Changes
Other Study ID Numbers: CR003925
EPO-IMU-402 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Epoetin alfa
Erythropoietin
Red Cell Aplasia, Pure
Chronic Renal Failure

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