What side effects are associated with this type of intervention?

Common treatments for chronic and end-stage kidney disease, such as those involving immunosuppressive therapies and pharmacological agents, often have a range of side effects. Immunosuppressive treatments can lead to increased rates of infections, impaired glucose tolerance, and weight gain. Specific drugs like methylprednisolone have been associated with serious infections and other adverse effects. Pharmacological agents used in kidney disease management can also cause gastrointestinal distress, fatigue, hypertension, and electrolyte imbalances. In some cases, severe toxicities such as nephrotoxicity, cardiomyopathy, and thrombotic microangiopathy have been reported.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of chronic and end-stage kidney disease, focusing on their pharmacokinetic and pharmacodynamic properties. Notable examples include erythropoiesis-stimulating agents like epoetin alfa and darbepoetin alfa, which manage anemia in CKD patients. Additionally, phosphate binders such as sevelamer and lanthanum carbonate are used to control hyperphosphatemia. More recently, drugs like patiromer and sodium zirconium cyclosilicate have been approved to manage hyperkalemia in CKD patients. These treatments share a focus on managing complications and improving the quality of life for patients with advanced kidney disease, similar to the goals of the MK-2060 study.

What other types of research exist?

Promising novel alternatives to MK-2060 for kidney failure patients include: 1) Ferric pyrophosphate citrate (FPC), which has shown efficacy in CKD-5HD patients, particularly in managing iron levels. 2) Sucroferric oxyhydroxide, used as part of combination phosphate binder therapy, which has demonstrated effectiveness in controlling serum phosphate levels in hemodialysis patients. 3) Continuous peritoneal dialysis (PD), which can be an alternative to hemodialysis in patients with congestive heart failure and chronic kidney disease, offering a different approach to managing fluid overload and waste removal.

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Monoclonal Antibodies

MK-2060 for Kidney Disease

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Has a history of or current frequent epistaxis within the last 3 months or active gingivitis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of MK-2060 aren't listed here, common risks may include injection site reactions like pain or swelling, potential allergic reactions to new medication components, general discomforts such as headaches or nausea that can occur during drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

I have received treatments like IVIG or RhoGAM in the past year.

Select...

I have no major dental or surgical procedures planned during the study.

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I have had GI bleeding, stomach ulcers, or severe hemorrhoids recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Apparent Total Clearance (CL/F) of MK-2060

Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060

Part 1: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-2060

+30 more

Secondary study objectives

Part 1: Percent Change from Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060

Part 2: Percent Change from Baseline in aPTT of MK-2060

Part 3: Percent Change from Baseline in aPTT of MK-2060

Side effects data

From 2021 Phase 1 trial • 38 Patients • NCT03873038

Myocardial infarction

Nausea

Sneezing

100%

80%

60%

40%

20%

Study treatment Arm

Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance

Part 1: Panel A- MK-2060 (8 mg)

Part 2: Placebo

Part 1: Panel B- MK-2060 (20 mg)

Part 1: Panel C- MK-2060 (40 mg)

Part 1: Placebo

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3: MK-2060Experimental Treatment1 Intervention

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

Group II: Part 2: MK-2060Experimental Treatment1 Intervention

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

Group III: Part 1: MK-2060Experimental Treatment1 Intervention

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

Group IV: Part 2: PlaceboPlacebo Group1 Intervention

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

Group V: Part 1: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-2060

2019

Completed Phase 1

~90

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure include dialysis, medications, and lifestyle changes. Dialysis mechanically removes waste products and excess fluids from the blood, mimicking kidney function. Medications such as erythropoiesis-stimulating agents (ESAs) manage anemia by stimulating red blood cell production, while phosphate binders control phosphate levels to prevent bone disease. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) help manage blood pressure and reduce proteinuria, slowing kidney damage. The study of MK-2060 focuses on its pharmacokinetics and pharmacodynamics, which are crucial for understanding how the drug is absorbed, distributed, metabolized, and excreted in patients with chronic and end-stage kidney disease. This knowledge helps optimize dosing, minimize side effects, and improve therapeutic outcomes for kidney failure patients.

Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.