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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Chronic Kidney Disease; Anemia

Treatments: Drug: Comparator: darbepoetin alfa; Drug: MK2578

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968617

2009_653

2578-002

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 4 patient groups

MK2578 1.0 mcg/kg

Experimental group

Description:

MK2578

Treatment:

Drug: MK2578

Drug: MK2578

Drug: MK2578

MK2578 2.0 mcg/kg

Experimental group

Description:

MK2578

Treatment:

Drug: MK2578

Drug: MK2578

Drug: MK2578

MK2578 3.6 mcg/kg

Experimental group

Description:

MK2578

Treatment:

Drug: MK2578

Drug: MK2578

Drug: MK2578

Darbepoetin alfa

Active Comparator group

Description:

darbepoetin alfa

Treatment:

Drug: Comparator: darbepoetin alfa