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

NCT00210951 | Completed

• 2 other identifiers: CR003925EPO-IMU-402
• Study Type: observational
• Target: 4,761
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Red-Cell Aplasia, Pure; Chronic Renal Failure

Keywords

Epoetin alfa; Erythropoietin; Red Cell Aplasia, Pure; Chronic Renal Failure

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Pure Red Cell Aplasia (PRCA)

  The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.

  Up to 2 years

• Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies

  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.

  Up to 2 years

• Relationship between EPO Antibodies and PRCA

  Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.

  Up to 2 years

Secondary Outcomes (3)

• Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration

  Every 3 Months up to up to 2 years

• Change From Baseline in Number of Participants With PRCA Over Time

  Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24

• Duration of Exposure

  Up to 2 years

Study Arms (1)

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

Interventions

No Intervention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• 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

MeSH Terms

Conditions

Red-Cell Aplasia, Pure; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: March 24, 2015

Record last verified: 2015-03