Clinical trial

Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia…

NCT00391287 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00391287
Title Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
Official title A Prospective, Immunogenicity Surveillance Registry (PRIMS) to Estimate the Incidence of Erythropoietin Antibody-Mediated Pure Red Cell Aplasia Among Subjects With Chronic Renal Failure and Subcutaneous Exposure to Recombinant Erythropoietin Products
Acronym PRIMS
Lead sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry
Collaborators Janssen-Cilag International NV Industry
Status Completed
Study type Observational
Conditions Pure Red-Cell Aplasia, Chronic Kidney Failure
Enrollment 15,334
Start date Jun 1, 2006
Primary completion Dec 1, 2010
Completion Dec 1, 2010
First posted Oct 23, 2006
Last update posted Oct 3, 2014
Countries Australia, Belgium, Denmark, Finland, Germany, Greece, Ireland, Netherlands, Norway, Poland, Portugal, Spain and 3 more

At a glance

  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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