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

NCT00924781 | Terminated Phase 2 Results

• 2 other identifiers: 2578-0032009_603
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

Anemia associated with chronic kidney disease (CKD); Hemodialysis

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Hemoglobin (Hg) Level at Week 4

  4 weeks

• Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

  12 weeks

• Number of Participants With Composite Events of Transfusion-Related Adverse Experiences

  12 weeks

• Number of Participants With Composite Events of Infusion Reactions

  12 weeks

• 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

  12 weeks

• Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578

  12 weeks

Secondary Outcomes (1)

• Change From Baseline in Hg Level at Week 12

  12 weeks

Study Arms (6)

MK2578 1 mcg for every 600 U of Epogen at Baseline

EXPERIMENTAL

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

1 mcg of MK2578 for every 600 U of Epogen at Baseline

EXPERIMENTAL

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 1 mcg for every 350 U of Epogen at Baseline

EXPERIMENTAL

Participants were randomized to receive treatment QW.

Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline

1 mcg of MK2578 for every 350 U of Epogen at Baseline

EXPERIMENTAL

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 1 mcg for every 200 U of Epogen at Baseline

EXPERIMENTAL

Participants were randomized to receive treatment QW.

Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline

1 mcg of MK2578 for every 200 U of Epogen at Baseline

EXPERIMENTAL

Participants were randomized to receive treatment QM.

Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline

Interventions

MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline DRUG

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.

1 mcg of MK2578 for every 600 U of Epogen at Baseline; MK2578 1 mcg for every 600 U of Epogen at Baseline

MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline DRUG

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.

1 mcg of MK2578 for every 350 U of Epogen at Baseline; MK2578 1 mcg for every 350 U of Epogen at Baseline

MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline DRUG

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.

1 mcg of MK2578 for every 200 U of Epogen at Baseline; MK2578 1 mcg for every 200 U of Epogen at Baseline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Cohort 3 (MK2578 1mcg/200U) was not initiated because the study was prematurely terminated by the sponsor. All randomized participants received at least one dose of study medication. Data presented are for Cohort 1 and Cohort 2, where applicable.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 2, 2015
• Results First Posted: March 29, 2012

Record last verified: 2015-10