A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

Last updated: August 23, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Nephropathy

Kidney Failure (Pediatric)

Renal Failure

Treatment

MK-2060

Placebo

Clinical Study ID

NCT05656040
2060-011
MK-2060-011
  • Ages 18-80
  • All Genders

Study Summary

This is a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) or stage 5 chronic kidney disease (CKD5) participants in Part 1, of multiple subcutaneous doses in CKD4 or CKD5 participants in Part 2, and of a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease in Part 3. The primary hypothesis is that, in Part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 or CKD5 participants is at least 11300 nM*hr.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) orend-state kidney disease on peritoneal dialysis (Part 3).

  • Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Exclusion

Exclusion Criteria:

  • Has a history of cancer, including adenocarcinoma, except adequately treatednon-melanomatous skin carcinoma or carcinoma in situ of the cervix or othermalignances which have been successfully treated ≥ 5 years prior to prestudy withappropriate follow-up.

  • Has a history of deep vein thrombosis or pulmonary embolism, a history of vascularaccess thrombosis within 1 month prior to enrollment, or has a personal or familyhistory of bleeding disorder.

  • Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcerin the last 5 years or severe hemorrhoidal bleed in the last 3 months.

  • Has a history of or current frequent epistaxis within the last 3 months or activegingivitis.

  • Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.

  • Has planned significant dental procedures at the time of screening or pre-dose orother planned surgical procedures within duration of participation of study.

  • Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).

  • Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL)within 4 weeks prior to the pre-study visit.

  • Has a history (participant recall) of receiving any human immunoglobulin preparationsuch as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.

  • Has a history (participant recall) of receiving any biological therapy (includinghuman blood products or monoclonal antibodies; excluding erythropoietin and insulin)within the last 3 months or vaccination within the last 1 month, except the seasonalflu and pneumococcal vaccine or COVID-19 vaccine.

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: MK-2060
Phase: 1
Study Start date:
February 08, 2023
Estimated Completion Date:
August 12, 2024

Connect with a study center

  • Velocity Clinical Research, New Smyrna Beach ( Site 0003)

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Advanced Pharma CR, LLC ( Site 0006)

    Miami, Florida 33147
    United States

    Site Not Available

  • Genesis Clinical Research, LLC ( Site 0004)

    Tampa, Florida 33603
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC ( Site 0002)

    Knoxville, Tennessee 37920
    United States

    Site Not Available

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