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

NCT00968617 | Terminated Phase 2 Results

• 2 other identifiers: 2578-0022009_653
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

Anemia

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Hemoglobin Level at Week 4

  4 weeks

• 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

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

  16 Weeks

• Number of of Participants With Composite Events of Injection Site Reactions

  16 Weeks

• Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia

  16 Weeks

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

  16 Weeks

Secondary Outcomes (3)

• Hemoglobin Concentration After Treatment With MK2578

  Weeks 1-10 and Week 12

• Change From Baseline in Hemoglobin Level

  Weeks 1-3, 5-10, and Week 12

• Number of Participants Who Were Responders

  Each week up to 12 weeks

Study Arms (4)

MK2578 1.0 mcg/kg

EXPERIMENTAL

MK2578

Drug: MK2578

MK2578 2.0 mcg/kg

EXPERIMENTAL

MK2578

Drug: MK2578

MK2578 3.6 mcg/kg

EXPERIMENTAL

MK2578

Drug: MK2578

Darbepoetin alfa

ACTIVE COMPARATOR

darbepoetin alfa

Drug: Comparator: darbepoetin alfa

Interventions

MK2578 DRUG

MK2578 1.0 mcg/kg/month

MK2578 1.0 mcg/kg

Comparator: darbepoetin alfa DRUG

darbepoetin alfa

Darbepoetin alfa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

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

Limitations and Caveats

Cohort 1 (MK2578 1.0 mcg/kg) was the only cohort initiated because the study was prematurely terminated by the sponsor. 7 participants received at least 1 dose of MK2578 \& 2 participants received all 3 doses. Data presented are for Cohort 1.

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: August 27, 2009
• First Posted: August 31, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 2, 2015
• Results First Posted: November 11, 2011

Record last verified: 2015-10