Clinical Trials Detalhe
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
General Information
Gender
ALL
Age
N/A
Phase
N/A
Study Type
OBSERVATIONAL
Location
Aveiro, Portugal
Barcelos, Portugal
Braga, Portugal
Coimbra, Portugal
Evora, Portugal
Faro, Portugal
Leiria, Portugal
P-1100 Lisboa N/A, Portugal
Portalegre, Portugal
Porto, Portugal
S. Joao Da Madeira, Portugal
Setúbal, Portugal
Viana do Castelo, Portugal
Vila Nova de Gaia, Portugal
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00391287Summary
The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA; aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving subcutaneous (s.c.) epoetin alfa (polysorbate 80 formulation) for the treatment of anemia associated with chronic renal failure (CRF), and to compare this incidence rate to the incidence rate with s.c. exposure to other currently marketed recombinant erythropoietin products (epoetin alfa, epoetin beta, darbepoetin alfa), with adjustment of duration for which the drug is given to the patient. The study will also examine the impact of the pattern of using mixed s.c. exposure to multiple erythropoietin products occurring in this patients, and the impact of the time from which the treatment is started to the onset of PRCA.
Conditions
Pure Red-Cell Aplasia
Chronic Kidney Failure
Eligibility
Inclusion Criteria: * Patients with established CRF as an indication for the treatment of anemia * Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin (i.e., epoetin alfa \[EPREX/ERYPO/GLOBUREN\], epoetin beta \[NEORECORMON®\], or darbepoetin alfa \[ARANESP®\]) by the s.c. route of administration * Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year. Exclusion Criteria: * Patients with a history of pure red cell aplasia or aplastic anemia * Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment * Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy) * Patients with a history of EPO antibodies prior to enrollment * Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to \>15 mg/day prednisolone * Subjects whose first s.c. exposure to any erythropoietin product was \>1 year prior to enrollment.