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).

Condition	Phase
Red-Cell Aplasia, Pure Kidney Failure, Chronic	Phase IV

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

Expected Total Enrollment:  750

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.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• The following inclusion criteria are applicable to index patients only: Patients must have met all inclusion criteria as specified in study EPO-IMU-301
• Male or female patients of any age
• Patients with a history of anemia due to chronic kidney disease
• Evidence of Pure Red Cell Aplasia (PRCA, a rare type of anemia) associated with treatment with an erythropoietin marketed by Johnson and Johnson (epoetin alfa), defined as receiving an effective dose of epoetin alfa for at least 30 days followed by a sudden decrease (> = 2 g/dL within 30 days) in a previously stable hemoglobin level that is not due to another cause and 1 of the following: a) Bone marrow testing showing a decrease in the number of immature red blood cells and/or a diagnosis of PRCA, b) Bone marrow testing showing low numbers of immature red blood cells or non-diagnostic findings associated with a decrease in the number of immature red blood cells, or c) A decrease in the number of immature red blood cells in cases where bone marrow testing was not performed
• Patients who experienced a decrease in the effectiveness of epoetin alfa and who had antibodies to erythropoietin during the period of decreased effectiveness
• Patients who received treatment with epoetin alfa for at least 2 months before the decreased effectiveness. The following inclusion criteria are applicable to control patients only: Male or female of any age
• Patients with a history of anemia due to chronic kidney disease
• Patients who received treatment with epoetin alfa for at least 2 months and whose treatment period with epoetin alfa was within 3 months before or 3 months after the date of decreased effectiveness to epoetin alfa for the index patient to whom they are being matched

Exclusion Criteria:

• The following exclusion criteria are applicable to index patients only: Patients who do not satisfy all inclusion criteria for study EPO-IMU-301
• Patients who do not satisfy all inclusion criteria in 11a (index patients only) above
• The following exclusion criteria are applicable to control patients only: Patients who do not satisfy all inclusion criteria in 11a (control patients only) above
• Patients for whom medical history and information related to past exposure to epoetin alfa is not available
• Patients with a known history of PRCA or antibodies to erythropoietin before or after the date of decreased effectiveness to epoetin alfa for the index patient to whom they are being matched

Please refer to this study by ClinicalTrials.gov identifier  NCT00211068

This study is not yet recruiting patients. Please check back for future recruiting sites, or email       info1@veritasmedicine.com

Belgium
      Montreal,  H2X3J4,  Belgium
Brazil
      São Paulo,  01409 902,  Brazil
      Sorocaba,  18040-460,  Brazil
Canada, Quebec
      Greenfield Park,  Quebec,  J4V 2H1,  Canada
Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7N0W8,  Canada
France
      Orleans Cedex 02,  45067,  France
      Paris Cedex 20,  75970,  France
      Bois Guillaume Cedex,  76233,  France
      Nantes Cedex 2,  44202,  France
      Grenoble Cedex 1,  38028,  France
Netherlands
      Roermond,  6043 CV,  Netherlands
Norway
      Tvnsberg,  3103,  Norway
South Africa
      Bloemfontein,  9300,  South Africa
Sweden
      Karlshamn,  374 80,  Sweden
      Stockholm,  182 88,  Sweden
      Trollhättan,  461 85,  Sweden
Thailand
      Bangkok,  10400,  Thailand
United Kingdom
      Westcliff-On-Sea,  SSO 0RY,  United Kingdom
      Ipswich,  IP4 5PD,  United Kingdom
      Edinburgh,  EH16 4SA,  United Kingdom
      London,  SE5 9RS,  United Kingdom
      Manchester,  M13 9WL,  United Kingdom
      Bristol,  BS10 5NB,  United Kingdom
      Birmingham,  B9 5SS,  United Kingdom
      Brighton,  BN2 5BE,  United Kingdom
      London,  W6 8RF,  United Kingdom
      Chelmsford,  CM1 7ET,  United Kingdom
      Omagh,  00000,  United Kingdom

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

Study ID Numbers:  CR004408
Last Updated:  October 31, 2006
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00211068
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-11-14