A Study to Collect Information About Risk Factors in the Development of a Rare Form of Anemia (Pure Red Cell Aplasia; PRCA) and Antibodies to Erythropoietin From Patients With Kidney Disease Treated With Epoetin Alfa
The purpose of this study is to collect and compare information from patients with chronic kidney disease who were treated with a recombinant erythropoietin marketed by the Johnson and Johnson family of companies who did or did not develop Pure Red Cell Aplasia (PRCA, a rare form of anemia).
Pure Red Cell Aplasia (PRCA), a rare type of anemia, may be associated with a loss of erythropoietin effectiveness in patients receiving recombinant erythropoietin. Post marketing data show that patients who later developed PRCA (with antibodies to erythropoietin) often demonstrated an initial positive response to treatment with recombinant erythropoietin which was followed by a loss of effectiveness. Some patients however have anti-erythropoietin antibodies without an apparent loss of effect of their recombinant erythropoietin treatment. In this study, information will be collected from patients with chronic kidney disease who were treated with a recombinant erythropoietin marketed by the Johnson and Johnson family of companies (epoetin alfa). This study is a companion study to another Johnson and Johnson study, in which the treatment and outcome of patients with PRCA associated with recombinant erythropoietin use and antibodies to erythropoietin were followed for a period of up to 4 years. Information will be collected from patients in this other similar Johnson and Johnson study who have chronic kidney disease treated with epoetin alfa, antibodies to erythropoietin and PRCA (index patients) and will be compared to information collected from similar patients who have chronic kidney disease treated with epoetin alfa who have not developed PRCA or antibodies to erythropoietin (control patients). All patients will be enrolled from facilities conducting the other similar Johnson and Johnson study. Control patients will be matched to index patients with regard to their chronic kidney disease, timing of exposure to epoetin alfa and location; up to 4 control patients may be enrolled per index patient. Risk factor information for control patients will be collected retrospectively from the control patients' medical records. As the study involves only the collection of historical information, no treatment will be specified and no medication will be supplied by the Sponsor of the study (Johnson and Johnson Pharmaceutical Research and Development, LLC). Information regarding risk factors possibly related to the development of PRCA associated with antibodies to erythropoietin will be collected from all patients. Risk factors will be divided into 3 types: drug-related risk factors (type of epoetin alfa used), drug administration-related risk factors (the way epoetin alfa was given [under the skin, slowly through a vein; in the hospital or clinic or at home], length of treatment with any recombinant erythropoietin and frequency of administration), and patient-related risk factors (age, sex, race, diagnosis of kidney disease, medical history, number of red blood cell transfusions, dialysis and transplantation history, chemotherapy, and medications other than erythropoietins). The date each index patient in the similar Johnson and Johnson study first demonstrated loss of erythropoietin effectiveness will be called the "reference date". Control patients will be selected based upon meeting the specific inclusion and exclusion criteria assessed relative to their respective index patient's reference date. Information will be collected for a period of up to 5 years before the reference date for all patients. Information for patients in the similar Johnson and Johnson study who have died or whose PRCA has resolved, as well as control patients who have died will also be collected, in accordance with local regulations regarding access to medical records of deceased patients. Patients may also participate in an optional portion of the study in which their genetic material will be analyzed to see if it contains something that would cause their immune system to make antibodies to erythropoietin. The study hypothesis is that in patients with chronic kidney disease a possible relationship exists between the number of risk factors to PRCA associated with erythropoietin antibodies and the chance of developing PRCA associated with erythropoietin antibodies.
Since the study involves only retrospective data collection, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor.
Time Perspective: Retrospective
Kidney Failure, Chronic
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00211068
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)
Kidney Papillary Necrosis
A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.
Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.
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