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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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)

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.

Detailed Summary: 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.
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome:

• 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.
• 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.
• 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.

Original Primary Outcome:

Current Secondary Outcome:

• 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.
• 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.
• 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.

Original Secondary Outcome:

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: September 13, 2005
Date Started: May 2003
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015