Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure (PRIMS)
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Immunogenicity Surveillance Registry (PRIMS) to Estimate the Incidence of Erythropoietin Antibody-Mediated Pure Red Cell Aplasia Among Subjects With Chronic Renal Failure and Subcutaneous Exposure to Recombinant Erythropoietin Products |
- estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA) [ Time Frame: Unexplained Loss of Effect (LOE) follow-up ] [ Designated as safety issue: No ]estimate the incidence rate of EPO antibody-mediated PRCA with s.c. exposure to the polysorbate 80 formulation of epoetin alfa 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.
- sensitivity analyses [ Time Frame: Unexplained Loss of Effect (LOE) follow-up ] [ Designated as safety issue: No ]to examine, in sensitivity analyses of the incidence rates of EPO antibody-mediated Pure Red Cell Aplasia (PRCA) and their rate ratios, the impact of the patterns of mixed s.c. exposure to multiple erythropoietin products occurring in this subject population and of varying the assumption of 1 to 12 months for latency from exposure to the onset of PRCA
| Enrollment: | 15333 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2010 |
| Groups/Cohorts |
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erythropoietin treatment in CRF
Patients exposed to EPREX or other marketed erythropoietin products administered by the subcutaneous route of administration for the treatment of anemia of Chronic Renal Failure
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All patients should have documented chronic renal failure (CRF) and be receiving or about to receive (within 1 month) a marketed erythropoietin product by the subcutaneous route of administration at the time of enrollment. Patients may be at any stage of CRF (Stages 1 to 5) or be receiving any treatment for CRF, including predialysis, peritoneal dialysis, or hemodialysis, but should not be receiving immunosuppressive treatment following an organ transplant.
Patients will be enrolled at sites located in the E.U. and Australia.
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.
Contacts and Locations
Show 382 Study Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided
| Responsible Party: | EMEA Medical Affairs Director Oncology, Janssen-Cilag Greece |
| ClinicalTrials.gov Identifier: | NCT00391287 History of Changes |
| Other Study ID Numbers: | CR011587, EPOANE4014, 001992-001 |
| Study First Received: | October 20, 2006 |
| Last Updated: | February 17, 2012 |
| Health Authority: | United States: Institutional Review Board France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
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Red-Cell Aplasia due to Chronic Kidney Failure Aplastic Anemia Recombinant Erythropoietin Surveillance Registry Registries |
Additional relevant MeSH terms:
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Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Red-Cell Aplasia, Pure Kidney Diseases Urologic Diseases Anemia |
Hematologic Diseases Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013