Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
420 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal