Status:
TERMINATED
A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD)...
Eligibility Criteria
Inclusion
- Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
- Patient has chronic kidney disease
Exclusion
- Patient is morbidly obese
- Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
- Patient will require dialysis during the study or is planning to have 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 the past 12 weeks or plans to have surgery
- Patient has Human Immunodeficiency Virus (HIV)
- Patient has a history of diseases other than CKD known to cause anemia
- Patient has severe congestive heart failure
- Patient has history of malignant cancer, except certain skin or cervical cancers
- Patient has a history of grand mal seizures within the last 6 months
- Patient is pregnant or breastfeeding
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00968617
Start Date
November 1 2009
End Date
May 1 2010
Last Update
November 2 2015
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