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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210951
First received: September 13, 2005
Last updated: March 23, 2015
Last verified: March 2015

September 13, 2005
March 23, 2015
May 2003
July 2005   (final data collection date for primary outcome measure)
  • Number of Participants With Pure Red Cell Aplasia (PRCA) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
  • Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.
  • Relationship between EPO Antibodies and PRCA [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.
Not Provided
Complete list of historical versions of study NCT00210951 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
  • Change From Baseline in Number of Participants With PRCA Over Time [ Time Frame: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
    The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
  • Duration of Exposure [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Duration of exposure to study medication is the time between the first and last dose of study medication.
Not Provided
Not Provided
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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
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
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.
  • Red-Cell Aplasia, Pure
  • Chronic Renal Failure
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.
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.
Intervention: Other: 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
4761
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00210951
CR003925, EPO-IMU-402
No
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
March 2015

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