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Experimental kidney drug MK-2060 passes first safety check in small study

NCT ID NCT05656040

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tested a single shot of an experimental drug called MK-2060 in 14 people with stage 4 chronic kidney disease. The main goal was to see if it was safe and how the body handles it. Only the first part of the study was completed; the later parts were not started for reasons unrelated to safety. The drug is designed to affect blood clotting, so researchers closely watched for any bleeding problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-2060 (an experimental biologic given as a shot under the skin)
What this could lead to
If successful, MK-2060 could become a new option to help control blood clotting in people with advanced kidney disease.
What could go wrong
This is a very early Phase 1 study with only 14 participants, and only Part 1 was completed. The drug may not prove safe or effective in larger trials, and bleeding risks are a key concern.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advanced Pharma CR, LLC ( Site 0006)

    Miami, Florida, 33147, United States

  • Alliance for Multispecialty Research, LLC ( Site 0002)

    Knoxville, Tennessee, 37920, United States

  • Genesis Clinical Research, LLC ( Site 0004)

    Tampa, Florida, 33603, United States

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

    Edgewater, Florida, 32132, United States

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