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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00968617
First received: August 27, 2009
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
 Drug: MK2578
Drug: Comparator: darbepoetin alfa
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin Level at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Composite Events of Transfusion-related Adverse Experiences [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Number of of Participants With Composite Events of Injection Site Reactions [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemoglobin Concentration After Treatment With MK2578 [ Time Frame: Weeks 1-10 and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Hemoglobin Level [ Time Frame: Weeks 1-3, 5-10, and Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Who Were Responders [ Time Frame: Each week up to 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK2578 1.0 mcg/kg
MK2578
 Drug: MK2578
MK2578 1.0 mcg/kg/month
Experimental: MK2578 2.0 mcg/kg
MK2578
 Drug: MK2578
MK2578 2.0 mcg/kg/month
Experimental: MK2578 3.6 mcg/kg
MK2578
 Drug: MK2578
MK2578 3.6 mcg/kg/month
Active Comparator: Darbepoetin alfa
darbepoetin alfa
 Drug: Comparator: darbepoetin alfa
darbepoetin alfa

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968617

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00968617     History of Changes
Other Study ID Numbers: MK-2578-002, 2009_653
Study First Received: August 27, 2009
Results First Received: October 7, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Anemia

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
 Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013