A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who are on Hemodialysis
- Conditions
- Anemia in patients with Kidney Disease (CKD)
- Registration Number
- EUCTR2009-010904-27-BG
- Lead Sponsor
- Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Patient is a male or female between 18 to 65 years of age and weighs between 40 and 90 kg (dry weight) at Screening Visit 1.
Note: Patient must meet the current age criteria for Cohort 1. When Cohort 1 is completely enrolled and the cohort data has been analyzed, and if there are no safety issues with respect to age, the Sponsor may allow for patients for up to age 70 to be enrolled; however, this liberalization of age criterion will be communicated to sites.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method