Description:

ODM derived from http://clinicaltrials.gov/show/NCT00391287

Link:

http://clinicaltrials.gov/show/NCT00391287

Keywords:
Versions (1) ▾
  1. 12/9/13
Uploaded on:

December 9, 2013

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00391287 Pure Red-Cell Aplasia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
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