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.) EPREX (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 for duration of exposure. The study will also examine the impact of the patterns of mixed s.c. exposure to multiple erythropoietin products occurring in this subject population, and the impact of the time from exposure to the onset of PRCA.

Official Title

ERA Safety Registry Study

Conditions

Chronic Kidney Failure, Pure Red-Cell Aplasia

Study Type

Observational

Study Design

Natural History, Longitudinal, Defined Population, Prospective Study

Further Details

This is a multicenter, multinational, immunogenicity surveillance registry using a prospective cohort design (patients identified by a common characteristic), with enrollment of parallel groups that are exposed to the polysorbate 80 formulation of EPREX or other marketed erythropoietin products administered by the s.c. route of administration for the treatment of anemia associated with CRF. The registry is designed to address the following question: Is the current rate of PRCA with the s.c. polysorbate 80 EPREX formulation using coated stoppers similar to the current rate with other marketed erythropoietin products administered by the s.c. route, adjusted for duration of exposure? Each patient will be observed for development of PRCA for up to 3 years. Information on exposure to erythropoietin products, stage of CRF, treatment modality for CRF, erythropoietin handling and storage information, and most recent hemoglobin level will be collected quarterly.

Study Start

June 2006

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

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 product 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

Total Enrolment

25,000 of which 600 will be Australian.

Contact Details

  • Randwick, 2031, Australia; Recruiting
  • Perth, 6847, Australia; Recruiting
  • Newcastle, 2305, Australia; Recruiting
  • Adelaide, 5000, Australia; Recruiting
  • Wollongong, 2521, Australia; Recruiting
  • Launceston, 7250, Australia; Recruiting
  • Hobart, 7000, Australia; Recruiting
  • Parkville, 3052, Australia; Recruiting
  • Woodville, 5011, Australia; Recruiting
  • Liverpool, 2170, Australia; Recruiting
  • Perth, 6009, Australia; Recruiting
  • Fremantle WA, 6160, Australia; Recruiting

European countries also recruiting. To see if you qualify or for questions on countries other than Australia recruiting, email: info1@veritasmedicine.com