A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)

Anemia Clinical Trial

Official title:

A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00924781
• Other study ID #: 2578-003
• Secondary ID: 2009_603
• Status: Terminated
• Phase: Phase 2
• First received: June 18, 2009
• Last updated: October 30, 2015
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.

Description:

This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Base Study:

• Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures

• Patient has been on hemodialysis for at least 6 months when informed consent is signed

• Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed

Extension Study:

• Patient completed the base study through Week 12

• Patient tolerated MK2578 and demonstrated compliance with study procedures

Exclusion Criteria:

• Patient has a life expectancy of less than 6 months

• Patient is scheduled for 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 12 weeks of screening or plans to have surgery

• Patient has Human Immunodeficiency Virus (HIV)

• Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia

• Patient has severe congestive heart failure (CHF)

• Patient has a history of malignant cancer, except certain skin or cervical cancers

• Patient has a history of grand mal seizures within the last 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline
MK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort.
• MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline
MK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.
• MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
MK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin (Hg) Level at Week 4		4 weeks	No
Primary	Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)		12 weeks	Yes
Primary	Number of Participants With Composite Events of Transfusion-Related Adverse Experiences		12 weeks	Yes
Primary	Number of Participants With Composite Events of Infusion Reactions		12 weeks	Yes
Primary	Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia		12 weeks	Yes
Primary	Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578		12 weeks	Yes
Secondary	Change From Baseline in Hg Level at Week 12		12 weeks	No