Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure (PRIMS)

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag International NV
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00391287
First received: October 20, 2006
Last updated: October 2, 2014
Last verified: October 2014
  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.


Condition Phase
Pure Red-Cell Aplasia
Chronic Kidney Failure
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: 15334
Study Start Date: June 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391287

  Show 391 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen-Cilag International NV
Investigators
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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00391287     History of Changes
Other Study ID Numbers: CR011587, EPOANE4014, 001992-001
Study First Received: October 20, 2006
Last Updated: October 2, 2014
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
Australia: Human Research Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Red-Cell Aplasia due to Chronic Kidney Failure
Aplastic Anemia
Recombinant Erythropoietin
Surveillance Registry
Registries

Additional relevant MeSH terms:
Kidney Failure, Chronic
Red-Cell Aplasia, Pure
Renal Insufficiency
Anemia
Hematologic Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014