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

NCT ID: NCT00211029

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4670 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-07-31

Brief Summary

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.

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. 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.

Conditions

Red-Cell Aplasia, Pure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=590&filename=CR004405_CSR.pdf

An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Erythropoietins

Other Identifiers

EPO-IMU-401

Identifier Type: OTHER

Identifier Source: secondary_id

CR004405

Identifier Type: -

Identifier Source: org_study_id