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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-08-12

Brief Summary

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This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) \[Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)\]. The primary hypothesis for Part 1 was that 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 participants would be at least 11300 nM\*hr.

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Detailed Description

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Conditions

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End-Stage Renal Disease End-Stage Kidney Disease Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MK-2060 30 mg

Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.

Group Type EXPERIMENTAL

MK-2060

Intervention Type BIOLOGICAL

MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously

Placebo

Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline administered subcutaneously

Interventions

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MK-2060

MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously

Intervention Type BIOLOGICAL

Placebo

Normal saline administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No