A Study of Four Dosing Regimens of PROCRIT® (Epoetin Alfa) in Patients with Chronic Kidney Disease - Article High blood pressure (hypertension)
Clinical Trial: A Study of Four Dosing Regimens of PROCRIT® (Epoetin Alfa) in Patients with Chronic Kidney Disease
This study is not yet open for patient recruitment.
Verified by Ortho Biotech Products, L.P. September 2005
|Kidney Diseases; Injections, Subcutaneous; Anemia || Drug: PROCRIT® (Epoetin alfa) ||Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Secondary Outcomes: Time to Hb response; patients with Hb > 11g/dL and an increase =>1g/dL from baseline during study; Final Hb change from baseline; Change in Hb over time; Treatment failures; Blood transfused; PROCRIT dose when Hb response is achieved and at end of study
Expected Total Enrollment: 210
- Must be 18 years or older; Subjects with reproductive potential and their partners must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study, female subjects with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of PROCRIT® (Epoetin alfa); Must have signed informed consent documents indicating that they agree to participate in the study, including the completion of all study-related procedures and evaluations; Must have Chronic Kidney Disease; Must have Hb < 11 g/dL at baseline; Must not have received any erythropoietic agents within 8 weeks before baseline.
- Transferrin saturation less than 20%; Iron overload defined as an iron saturation > 70% or a ferritin > 1000 ng/mL; A current diagnosis of poorly controlled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mmHg) after adequate antihypertensive therapy; Severe Congestive Heart Failure (New York Heart Association Class IV), or known severe stable or unstable coronary artery disease; Chemotherapy for cancer within 3 months prior to baseline or expected during study participation, Known solid tumor malignancy; New onset seizures within 3 months or seizures not controlled by medication prior to baseline; Current diagnosis of anemia due to Vitamin B12 deficiencies, hemolysis, or gastrointestinal bleeding; Any drug that may independently cause anemia; History of/or active blood dyscrasias, hematologic disorders, liver diseases or any other diseases known to cause anemia; A past history of thrombotic vascular events, including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis; Subjects with a life expectancy of <= 6 months; Receiving dialysis or scheduled to receive dialysis during the course of the study; Previous unresponsiveness to erythropoietic agents; Women who are currently pregnant or lactating; Currently participating or have participated in another experimental drug or device study within 30 days prior to the baseline.
Location and Contact Information
Ortho Biotech Products L.P., USA, Study Director, Ortho Biotech Products, L.P., USA
Last Updated: September 20, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00212875
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27
- High Blood Pressure and Kidney Disease (National Institute of Diabetes and Digestive and Kidney Diseases)