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

Sponsors and Collaborators: Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P., USA
Information provided by: Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier: NCT00212875

Purpose

The purpose of this study is to explore the Hemoglobin response in subjects with anemia of CKD initiated on one of four PROCRIT® (Epoetin alfa) dosing regimens.
Condition Intervention Phase
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

Official Title: An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT® (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD).

Further Study Details: 
Primary Outcomes: To explore hemoglobin response, defined as achieving a hemoglobin increase of greater than 1.0 g/dL from baseline anytime during the 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

This is an exploratory, open-label, randomized, multicenter study in pre-dialysis subjects with anemia of chronic kidney disease (CKD). The primary objective is to explore the hemoglobin (Hb) response, defined as achieving a Hb increase of > 1.0 g/dL from baseline anytime during the study, in subjects with anemia of CKD initiated on one of four PROCRIT® (Epoetin alfa) dosing regimens. This study will have a Screening Phase of up to one week, an open-label Treatment Phase of 16 weeks, and a Post-treatment Follow-Up Phase of 1 week. During the Treatment Phase, all subjects will be randomized to receive PROCRIT® (Epoetin alfa) administered SC at one of the four dosing regimens. There will be no dose adjustments during the initial 4 weeks of the study, however, the dose may be withheld during this period. Subjects will be eligible to receive dose adjustments starting at the Week 5 visit if Hb is greater than 12 g/dL or increased too rapidly. Hb will be measured weekly. Hematology, serum chemistry, and iron status will be assessed at intervals throughout the study. The number of units of blood transfused, pre-transfusion Hb level, and the reasons for transfusion will be collected. Clinical laboratory results, vital signs, and the incidence and severity of adverse events will be monitored during the study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00212875

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Ortho Biotech Products L.P., USA,  Study Director,  Ortho Biotech Products, L.P., USA   

More Information

Study ID Numbers:  CR003397
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

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