A Study to Observe the Number of Patients Who Develop Pure Red Cell Aplasia (PRCA, a Rare Form of Anemia) While Receiving Epoetin Alfa or Other Recombinant Erythropoietins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00211029
First received: September 13, 2005
Last updated: July 30, 2015
Last verified: July 2015

September 13, 2005
July 30, 2015
January 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 Development Associated With Different Routes of Administration [ 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 NCT00211029 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.
  • Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA [ Time Frame: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
    Data will be collected from PRCA cases and non-PRCA cases to assist with identification of risk factors for PRCA such as demographic profile and duration of exposure to epoetin alfa or other recombinant erythropoietins.
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A Study to Observe the Number of Patients Who Develop Pure Red Cell Aplasia (PRCA, a Rare Form of Anemia) While Receiving Epoetin Alfa or Other Recombinant Erythropoietins
An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Recombinant Erythropoietins
The purpose of this study is to record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.
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. The results of this study will be combined with a similar study (EPO-IMU-402) that also collects blood samples to observe the number of patients who develop antibodies to erythropoietin. 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. The study hypothesis is that these data will provide a framework for the expansion of the patient population to estimate the incidence of PRCA associated with the use of epoetin alfa or other recombinant erythropoietins for other therapeutic indications.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.
Red-Cell Aplasia, Pure
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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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4670
July 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients of legal age to give consent according to local standards
  • Patients 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 patients 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, patients must give consent to permit the collection of de-identified personal data for the specific purpose of this study

Exclusion Criteria:

  • Patients who are unable to complete future follow-up visits
  • Patients 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
  • Patients with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
  • Patients whose anemia did not respond to previous treatment with an erythropoietin
  • Patients 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
 
NCT00211029
CR004405, EPO-IMU-401
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.
July 2015

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