Anemia in patient with Kidney Disease (CKD) MedDRA version: 12.0 Level: LLT Classification code 10009120 Term: Chronic renal failure anaemia
Conditions
Interventions
Product Name: MK-2578 PEGylated Erythropoietin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equ
Sponsors
MERCK & CO., INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is a male or female between 18 to 65 years of age and weighs between 40 and 90 kg at Screening Visit 1. Patient is unlikely to conceive, as indicated by at least one ?yes? answer to the following questions: a) Patient is a male. b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female ≥ 45 years of age with > 2 years since last menses. d) Patient is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception. Patient is on hemodialysis for ≥ 3 months at the time of Screening Visit 1 and is adequately dialyzed as indicated by a Kt/V ≥ 1.2. Patient has received epoetin alfa or epoetin beta IV maintenance treatment for ≥ 6 months at the time of Screening Visit 1. In the 8 weeks prior to randomization, patient is continuously prescribed epoetin alfa or epoetin beta IV maintenance treatment at a dose between 50 to 250 U/kg/week that is administered on a consistent dosing schedule/ frequency. In the 3 weeks prior to randomization, a stable epoetin alfa or epoetin beta dose is required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has a life expectancy of less than 6 months. Patient is scheduled to have a kidney transplant within the next 6 months. A patient on the waiting list for a cadaveric transplant may participate. Patient has had a blood transfusion within 12 weeks of Screening Visit 1. Patient has had major surgery within the past 12 weeks or plans to have major surgery during the course of the study. Patient has poorly controlled hypertension (as per Investigator opinion), or patient has had an episode of hypertension necessitating interruption of epoetin treatment in the 6 months before Screening Visit 1. Patient has been diagnosed with human immunodeficiency virus. Patient has severe congestive heart failure (New York Heart Association Class III or IV) with symptoms that occur at rest or with minimal activity. Patient has a history of malignant neoplastic disease, except for adequately treated non-melanomatous skin lesions or carcinoma in situ of the cervix. Patient has had a thrombotic vascular event, including but not limited to myocardial infarction (MI), cerebrovascular accident (stroke, CVA), transient ischemic attack (TIA), pulmonary embolus, or deep vein thrombosis (DVT) within 6 months of randomization. Patient has a history of grand mal seizures within 6 months of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary: Change from baseline Hb at Week 4. Secondary: Change from baseline Hb at Week 12.;Main Objective: To define optimal factor (e.g. μg MK-2578 per U epoetin) for conversion of epoetin alfa or epoetin beta administered three times weekly (TIW), two times weekly (BIW), or weekly (QW) IV, to MK-2578, administered intravenously monthly or weekly that will maintain Hb at the baseline value (i.e., Hb change from baseline approximately 0 where baseline is defined as the average Hb value during the epoetin alfa/epoetin beta run-in period). To assess the safety and tolerability of MK-2578 (IV) in hemodialysis patients previously treated with epoetin alfa or epoetin beta.;Secondary Objective: 1) To evaluate the effect of dosing schedule (QW versus QM), for a given conversion factor, on change from baseline Hb. 2) To evaluate the performance of conversion factors over 12 weeks, as measured by change from baseline Hb by week and percentages of patients remaining within a target Hb range, requiring dose changes, and receiving transfusions. 3) To investigate the population pharmacokinetics of MK-2578 (IV) in CKD patients on hemodialysis. | — |
Countries
Bulgaria, Italy
Outcome results
None listed