Status:
COMPLETED
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen-Cilag International NV
Conditions:
Pure Red-Cell Aplasia
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
In 1998, prompted by concern that human serum albumin (HAS- the stabilizer in the epoetin alfa formulation) could theoretically transmit Creutzfeldt-Jakob disease and bovine spongiform encephalopathy,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
15334 Patients enrolled
Trial Details
Trial ID
NCT00391287
Start Date
June 1 2006
End Date
December 1 2010
Last Update
October 3 2014
Active Locations (387)
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1
Adelaide, Australia
2
Central Queensland M C, Australia
3
Fremantle, Australia
4
Hobart, Australia