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.

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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.

Overall Status Terminated
Start Date November 2009
Completion Date May 2010
Primary Completion Date April 2010
Phase Phase 2
Study Type Interventional
Primary 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
Measure 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 Each week up to 12 weeks
Enrollment 7
Condition
Intervention

Intervention Type: Drug

Intervention Name: MK2578

Description: MK2578 1.0 mcg/kg/month

Arm Group Label: MK2578 1.0 mcg/kg

Intervention Type: Drug

Intervention Name: MK2578

Description: MK2578 2.0 mcg/kg/month

Arm Group Label: MK2578 2.0 mcg/kg

Intervention Type: Drug

Intervention Name: MK2578

Description: MK2578 3.6 mcg/kg/month

Arm Group Label: MK2578 3.6 mcg/kg

Intervention Type: Drug

Intervention Name: Comparator: darbepoetin alfa

Description: darbepoetin alfa

Arm Group Label: Darbepoetin alfa

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Merck Sharp & Dohme Corp.
Verification Date

October 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: MK2578 1.0 mcg/kg

Type: Experimental

Description: MK2578

Label: MK2578 2.0 mcg/kg

Type: Experimental

Description: MK2578

Label: MK2578 3.6 mcg/kg

Type: Experimental

Description: MK2578

Label: Darbepoetin alfa

Type: Active Comparator

Description: darbepoetin alfa

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov