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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Centocor Ortho Biotech Services, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00641589 |
The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD).
Condition | Intervention | Phase |
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Anemia Chronic Kidney Disease |
Drug: epoetin alfa |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label, Randomized Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT® (Epoetin Alfa) in Anemic Subjects With Chronic Kidney Disease |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Study Completion Date: | November 2006 |
This is a prospective, open-label (both the patient and the physician know the drug and drug dose being given), randomized (patients are assigned to a dosing regimen by chance), multicenter, pharmacokinetic study in patients with anemia secondary to non-dialysis chronic kidney disease (CKD). A pharmacokinetic study is one that evaluates the process by which a drug is utilized by the body. Approximately 40 patients will participate in this study. This study has 3 Phases; the Screening Phase, the Open-Label Treatment Phase and Study Completion/Early Withdrawal Phase. In the Screening Phase, patients may be evaluated up to 14 days before study entry. The Treatment Phase begins when the patient is randomly assigned to a treatment group and continues until the patient has received the last dose of study drug. The Study Completion/Early Withdrawal Phase is the phase during which the last study-related procedures take place. This Phase should occur on Study Day 64 for the Q4W group and on Study Day 36 for all other dosing regimens.
Patients who satisfy all study inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to one of four treatment groups. Dosing will continue through Study Day 26 for treatment group A, through Study Day 22 for treatment group B, through Study Day 15 for treatment group C, and through Study Day 29 for treatment group D. No dose escalation or dose reductions are allowed during the study. Safety will be monitored by physical examinations, vital signes, clinical laboratory tests, and the occurrence and severity of any adverse events. Safety monitoring will continue through 30 days after the last visit for all treatment groups. Pharmacokinetic and pharmacodynamic (the study of the action or effects of drugs on the body) sampling will occur throughout the study. A patient evaluable for pharmacokinetic and pharmacodynamic parameters is one who receives the first scheduled dose of the assigned study drug, has a leaast 75% of the pharmacokinetic samples collected up to and including Day 29 for all groups, and does not receive any red blood cell (RBC) transfusions prior to Study Day 8. Pharmacokinetic evaluations will continue through Study Day 29 for groups A, B, C; through Study Day 57 for Group D, and will include but are not limited to: maximal serum concentrations of erythropoietin, time to reach maximal serum concentration and time for erythropoietin to be eliminated from the body. Pharmacodynamic evaluations continue through Study Day 36 for Groups A,B,C; thorugh Study Day 64 for Group D, and will include but are not limited to hemoglobin (Hg), hematocrit (Hct), total red blood cell (RBC) count. The primary objective of this study is to describe the pharmacokinetic profiles of four different dosing regimens of PROCRIT (epoetin alfa) in patients with anemia secondary to non-dialysis chronic kidney disease (CKD). The secondary objective is to describe the pharmacodynamic response to the four epoetin alfa study dosing regimens.
Patients will be randomly assigned to one of four dosing regimens of epoetin alfa: Group A: 50 IU (International Units)/kilogram (kg) three times per week (TIW); Group B: 10,000 IU once weekly (QW); Group C: 20,000 IU every 2 weeks (Q2W); and Group D: 40,000 IU every 4 weeks (Q4W).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR002299 |
Study First Received: | March 17, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00641589 History of Changes |
Health Authority: | United States: Food and Drug Administration |
anemia epoetin alfa Chronic Kidney Disease |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Hematologic Diseases |
Renal Insufficiency, Chronic Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Epoetin Alfa Renal Insufficiency Hematologic Diseases Hematinics Hematologic Agents Anemia Kidney Failure, Chronic |
Pharmacologic Actions Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Kidney Diseases Kidney Failure |