Status:
TERMINATED
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving ery...
Detailed Description
This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter t...
Eligibility Criteria
Inclusion
- Base Study:
- Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
- Patient has been on hemodialysis for at least 6 months when informed consent is signed
- Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed
- Extension Study:
- Patient completed the base study through Week 12
- Patient tolerated MK2578 and demonstrated compliance with study procedures
Exclusion
- Patient has a life expectancy of less than 6 months
- Patient is scheduled for a kidney transplant within the next 6 months
- Patient has had a blood transfusion within 12 weeks of screening
- Patient has had major surgery within 12 weeks of screening or plans to have surgery
- Patient has Human Immunodeficiency Virus (HIV)
- Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia
- Patient has severe congestive heart failure (CHF)
- Patient has a history of malignant cancer, except certain skin or cervical cancers
- Patient has a history of grand mal seizures within the last 6 months
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00924781
Start Date
June 1 2009
End Date
May 1 2010
Last Update
November 2 2015
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