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

NCT ID: NCT00968617

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-05-31

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) who are not on dialysis while evaluating its safety.

Conditions

Anemia; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK2578 1.0 mcg/kg

MK2578

Group Type: EXPERIMENTAL

MK2578

Intervention Type: DRUG

MK2578 1.0 mcg/kg/month

MK2578 2.0 mcg/kg

MK2578

Group Type: EXPERIMENTAL

MK2578

Intervention Type: DRUG

MK2578 2.0 mcg/kg/month

MK2578 3.6 mcg/kg

MK2578

Group Type: EXPERIMENTAL

MK2578

Intervention Type: DRUG

MK2578 3.6 mcg/kg/month

Darbepoetin alfa

darbepoetin alfa

Group Type: ACTIVE_COMPARATOR

Comparator: darbepoetin alfa

Intervention Type: DRUG

darbepoetin alfa

Interventions

MK2578

MK2578 1.0 mcg/kg/month

Intervention Type: DRUG

MK2578

MK2578 2.0 mcg/kg/month

Intervention Type: DRUG

MK2578

MK2578 3.6 mcg/kg/month

Intervention Type: DRUG

Comparator: darbepoetin alfa

darbepoetin alfa

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

Other Identifiers

2009_653

Identifier Type: -

Identifier Source: secondary_id

2578-002

Identifier Type: -

Identifier Source: org_study_id