Clinical trial NCT00968617: A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Chronic Kidney Disease
Keywords: Anemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Hemoglobin Level at Week 4
timeFrame: 4 weeks
measure: 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
timeFrame: 16 Weeks
measure: Number of Participants With Composite Events of Transfusion-related Adverse Experiences
timeFrame: 16 Weeks
measure: Number of of Participants With Composite Events of Injection Site Reactions
timeFrame: 16 Weeks
measure: Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
timeFrame: 16 Weeks
measure: Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
timeFrame: 16 Weeks
Secondary outcomes:
measure: Hemoglobin Concentration After Treatment With MK2578
timeFrame: Weeks 1-10 and Week 12
measure: Change From Baseline in Hemoglobin Level
timeFrame: Weeks 1-3, 5-10, and Week 12
measure: Number of Participants Who Were Responders
timeFrame: Each week up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: