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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00924781
First received: June 18, 2009
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline
Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline
Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
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 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin (Hg) Level at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Composite Events of Transfusion-Related Adverse Experiences [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Composite Events of Infusion Reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Hg Level at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 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 mcg for every 600 U of Epogen at Baseline
Participants were randomized to receive treatment every week (QW).
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.
Experimental: 1 mcg of MK2578 for every 600 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
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.
Experimental: MK2578 1 mcg for every 350 U of Epogen at Baseline
Participants were randomized to receive treatment QW.
Drug: 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.
Experimental: 1 mcg of MK2578 for every 350 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
Drug: 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.
Experimental: MK2578 1 mcg for every 200 U of Epogen at Baseline
Participants were randomized to receive treatment QW.
Drug: 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.
Experimental: 1 mcg of MK2578 for every 200 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
Drug: 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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924781

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00924781     History of Changes
Other Study ID Numbers: MK-2578-003, 2009_603
Study First Received: June 18, 2009
Results First Received: October 25, 2011
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Anemia associated with chronic kidney disease (CKD)
Hemodialysis

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

ClinicalTrials.gov processed this record on April 17, 2014