A Study to Observe Patients With Anemia Treated With Recombinant Erythropoietins Who Develop Antibodies to Erythropoietin
The purpose of this study is to observe patients with antibodies to erythropoietin who are being given a recombinant erythropoietin to treat or prevent anemia without loss of efficacy to see if they will develop Pure Red Cell Aplasia (PRCA, a rare type of anemia) or a loss of effectiveness to recombinant erythropoietin and to measure how long treatment with a recombinant erythropoietin is effective.
|Study Design:||Time Perspective: Prospective|
|Official Title:||An Observational Study of Subjects Treated With Recombinant Erythropoietins for Anemia Who Developed Anti-Erythropoietin Antibodies|
Pure Red Cell Aplasia (PRCA), a rare type of anemia, may be associated with a loss of erythropoietin effectiveness in patients receiving recombinant erythropoietin. Post marketing data show that patients who later developed PRCA (with antibodies to erythropoietin) often demonstrated an initial positive response to treatment with recombinant erythropoietin which was followed by a loss of effectiveness. Some patients however have anti-erythropoietin antibodies without an apparent loss of effect of their recombinant erythropoietin treatment.. In this observational, international, multicenter study, patients with antibodies to erythropoietin who are taking an erythropoietin receptor agonist to treat or prevent anemia of any cause (for example, chronic kidney disease, cancer, human immunodeficiency virus) will be observed to see if they develop PRCA or a loss of effectiveness to erythropoietin and to measure how long treatment with a recombinant erythropoietin is effective. Patients will be followed for a total of 3 years. During the first 2 years, patients' erythropoietin antibody status (positive or negative), clinical progress and treatment or prevention of anemia, and outcome will be followed. The third year will consist of collection of follow-up information by phone or in person. During the study, no treatment will be specified and no medication will be supplied by the Sponsor of the study (Johnson and Johnson Pharmaceutical Research and Development, LLC). Patients will be treated by their individual physicians for their anemia. Study visits and blood-sampling for study-specific tests will be done at regular intervals throughout the first 2 years (every month to every 3 months, depending on test results). Safety will be assessed throughout the study by recording adverse events, including complications of red blood cell transfusions, any new diagnoses which are identified through the course of the patients' regular treatment and care for anemia, adverse events related to recombinant erythropoietin use or PRCA, complications of treatments or procedures for loss of effectiveness or PRCA and study-specific procedures. Patients may also participate in an optional portion of the study in which their genetic material will be analyzed to see if it contains something that would cause their immune system to make antibodies to erythropoietin. The study hypothesis is that a possible relationship exists between erythropoietin antibodies and the clinical course and outcome of patients with anemia in patients treated with recombinant erythropoietins.
Since the study is an observation of patients with anemia, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor. Patients will receive standard-of-care treatment for their disease from their individual physicians.
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|