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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

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

About this trial

Last updated 10 years ago

Study ID

CR004405

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 20 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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