A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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) who are not on dialysis while evaluating its safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Darbepoetin alfa; Hematinics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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