Clinical trial NCT00924781: A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Chronic Kidney Disease
Keywords: Anemia associated with chronic kidney disease (CKD)
Hemodialysis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin (Hg) Level at Week 4
timeFrame: 4 weeks
measure: Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
timeFrame: 12 weeks
measure: Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
timeFrame: 12 weeks
measure: Number of Participants With Composite Events of Infusion Reactions
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Hg Level at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: