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

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00968617
• Other study ID #: 2578-002
• Secondary ID: 2009_653
• Status: Terminated
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: October 30, 2015
• Start date: November 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 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
MK2578 1.0 mcg/kg/month
• MK2578
MK2578 2.0 mcg/kg/month
• MK2578
MK2578 3.6 mcg/kg/month
• Comparator: darbepoetin alfa
darbepoetin alfa

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 Level at Week 4		4 weeks	No
Primary	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	Yes
Primary	Number of Participants With Composite Events of Transfusion-related Adverse Experiences		16 Weeks	Yes
Primary	Number of of Participants With Composite Events of Injection Site Reactions		16 Weeks	Yes
Primary	Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia		16 Weeks	Yes
Primary	Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578		16 Weeks	Yes
Secondary	Hemoglobin Concentration After Treatment With MK2578		Weeks 1-10 and Week 12	No
Secondary	Change From Baseline in Hemoglobin Level		Weeks 1-3, 5-10, and Week 12	No
Secondary	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	No