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

A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.

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.

Study Overview

• Status: Terminated
• Conditions: Anemia; Chronic Kidney Disease
• Intervention / Treatment: Drug: MK2578; Drug: MK2578; Drug: MK2578; Drug: Comparator: darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK2578 1.0 mcg/kg; MK2578	Drug: MK2578; MK2578 1.0 mcg/kg/month; Drug: MK2578; MK2578 2.0 mcg/kg/month; Drug: MK2578; MK2578 3.6 mcg/kg/month
Experimental: MK2578 2.0 mcg/kg; MK2578	Drug: MK2578; MK2578 1.0 mcg/kg/month; Drug: MK2578; MK2578 2.0 mcg/kg/month; Drug: MK2578; MK2578 3.6 mcg/kg/month
Experimental: MK2578 3.6 mcg/kg; MK2578	Drug: MK2578; MK2578 1.0 mcg/kg/month; Drug: MK2578; MK2578 2.0 mcg/kg/month; Drug: MK2578; MK2578 3.6 mcg/kg/month
Active Comparator: Darbepoetin alfa; darbepoetin alfa	Drug: Comparator: darbepoetin alfa; darbepoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Hemoglobin Level at Week 4	4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events	16 Weeks
Number of Participants With Composite Events of Transfusion-related Adverse Experiences	16 Weeks
Number of of Participants With Composite Events of Injection Site Reactions	16 Weeks
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia	16 Weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Concentration After Treatment With MK2578		Weeks 1-10 and Week 12
Change From Baseline in Hemoglobin Level		Weeks 1-3, 5-10, and Week 12
Number of Participants Who Were Responders	Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.	Each week up to 12 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Anemia
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 2578-002; 2009_653