MK-2060 for Kidney Disease

Recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, Thrombosis, Bleeding disorders, others

Compensation: Varies

Number of Visits: 9

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests MK-2060, a new medication, in people with severe kidney disease. It aims to see if the drug is safe and how it behaves in their bodies. The study focuses on patients with advanced stages of kidney disease who need new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but ongoing anticoagulant or antiplatelet therapy is not allowed, except for aspirin. It's best to discuss your specific medications with the trial team.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with stage 4 or 5 chronic kidney disease, or those on peritoneal dialysis due to end-stage kidney disease. Participants must have a BMI between 18 and 45 kg/m^2. People with recent cancer (except certain skin cancers), blood clots, bleeding disorders, ongoing anticoagulant therapy (except aspirin), recent major surgery or blood donation, immunoglobulin treatments within the last year, biological therapies in the past three months (excluding erythropoietin and insulin), GI bleeding issues in the past five years, frequent nosebleeds or active gingivitis are excluded.

Inclusion Criteria

I have severe chronic kidney disease or am on peritoneal dialysis.

Your body mass index (BMI) is between 18 and 45.

Exclusion Criteria

I have had frequent nosebleeds or gum disease in the last 3 months.

I am on blood thinners, but aspirin is okay.

You have hepatitis B or HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Single Dose Administration

Participants receive a single subcutaneous dose of MK-2060 or placebo

1 day

1 visit (in-person)

Part 2: Multiple Dose Administration

Participants receive multiple subcutaneous doses of MK-2060 or placebo

22 days

7 visits (in-person)

Part 3: Single Dose Administration for End-Stage Kidney Disease

Participants with end-stage kidney disease receive a single subcutaneous dose of MK-2060

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 144 days

Treatment Details

Interventions

• MK-2060

Trial Overview The study tests MK-2060's safety and effects when given as a single subcutaneous dose to people with advanced kidney disease. It has three parts: one for CKD stages 4 and 5 participants receiving one dose; another where they receive multiple doses; and a third part involving patients with end-stage kidney disease on dialysis.

Participant Groups

Group I: Part 3: MK-2060 Experimental Treatment 1 Intervention

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

Group II: Part 2: MK-2060 Experimental Treatment 1 Intervention

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

Group III: Part 1: MK-2060 Experimental Treatment 1 Intervention

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

Group IV: Part 2: Placebo Placebo Group 1 Intervention

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

Group V: Part 1: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University