Chronic Kidney Failure Clinical Trial
— PRIMSOfficial 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
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.
Status | Completed |
Enrollment | 15334 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Janssen-Cilag International NV |
Australia, Belgium, Denmark, Finland, Germany, Greece, Ireland, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | estimate the incidence rate of EPO antibody-mediated Pure Red Cell Aplasia (PRCA) | 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. | Unexplained Loss of Effect (LOE) follow-up | No |
Secondary | sensitivity analyses | 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 | Unexplained Loss of Effect (LOE) follow-up | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT00781690 -
Reduction of Heparin Dose in Dialysis With Evodial System
|
N/A | |
Completed |
NCT00806130 -
Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
|
||
Completed |
NCT00153621 -
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients
|
N/A | |
Completed |
NCT06165211 -
Nature-Based Sound Application For Hemodialysis Patients
|
N/A | |
Not yet recruiting |
NCT04013620 -
CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
Withdrawn |
NCT03998917 -
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
|
||
Completed |
NCT02586376 -
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
|
N/A | |
Completed |
NCT00794326 -
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
|
Phase 3 | |
Completed |
NCT05185999 -
Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
|
Phase 1 | |
Completed |
NCT03076528 -
An Innovative Virtually Supervised Exercise for Dialysis Patients
|
Phase 2 | |
Completed |
NCT02513303 -
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
Phase 3 | |
Completed |
NCT00804453 -
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
|
N/A | |
Unknown status |
NCT00788905 -
Comparison of Conventional Dialysis and the Allient System
|
N/A | |
Completed |
NCT01085552 -
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
|
Phase 1 | |
Completed |
NCT00694824 -
Vascular Calcification's Risk Factors in Haemodialysis Patients
|
||
Completed |
NCT00074620 -
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
|
Phase 2 | |
Withdrawn |
NCT06030050 -
Animal Assisted Intervention for Hemodialysis Outpatients
|
N/A | |
Recruiting |
NCT05562869 -
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
Completed |
NCT03437538 -
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
|
N/A |