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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Treatments: Drug: Placebo; Biological: MK-2060

Study type: Interventional

Funder types: Industry

Identifiers

NCT05656040

2060-011

MK-2060-011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3).
• Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Exclusion criteria

• Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.
• Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.
• Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in 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 active gingivitis.
• Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
• Has planned significant dental procedures at the time of screening or pre-dose or other 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 preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
• Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 5 patient groups, including a placebo group

Part 1: MK-2060

Experimental group

Description:

MK-2060 administered as a single subcutaneous dose of 30 mg on Day 1

Treatment:

Biological: MK-2060

Part 1: Placebo

Placebo Comparator group

Description:

Placebo (normal saline) administered as a single subcutaneous dose on Day 1

Treatment:

Drug: Placebo

Part 2: MK-2060

Experimental group

Description:

MK-2060 administered as multiple subcutaneous doses on Days 1, 2, 3, 4, 8, 15, and 22.

Treatment:

Biological: MK-2060

Part 2: Placebo

Placebo Comparator group

Description:

Placebo (normal saline) administered as multiple subcutaneous doses on Days 1, 2, 3, 4, 8, 15, and 22.

Treatment:

Drug: Placebo

Part 3: MK-2060

Experimental group

Description:

MK-2060 administered as a single subcutaneous dose on Day 1

Treatment:

Biological: MK-2060