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Monoclonal Antibodies
MK-2060 for Kidney Disease
Phase 1
Recruiting
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
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
Awards & highlights
Study Summary
This trial investigates the safety and effectiveness of a single dose of a drug (MK-2060) in people with advanced stage kidney disease.
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.Check my eligibility
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.See study design
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 belowSelect...
I have severe chronic kidney disease or am on peritoneal dialysis.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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
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
~70
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,638 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,711 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not had major surgery or donated/lost significant blood in the last 4 weeks.I haven't received any biological therapy or vaccines (except for flu, pneumococcal, or COVID-19) in the past 3 months.I have no major dental or surgical procedures planned during the study.I have received treatments like IVIG or RhoGAM in the past year.I had cancer before, but it was either skin cancer treated well, cervical pre-cancer, or any cancer treated successfully over 5 years ago.I have had blood clots or a family history of bleeding disorders.I have had GI bleeding, stomach ulcers, or severe hemorrhoids recently.I have severe chronic kidney disease or am on peritoneal dialysis.Your body mass index (BMI) is between 18 and 45.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Placebo
- Group 2: Part 1: MK-2060
- Group 3: Part 2: MK-2060
- Group 4: Part 1: Placebo
- Group 5: Part 3: MK-2060
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age restriction for this research project extend past thirty-five years of age?
"This trial is open to adults aged 18 to 80. However, there are numerous trials with age exclusions; 52 options for those under the legal age of consent and 604 studies available for elderly individuals above 65 years old."
Answered by AI
Are there any openings available for this trial at the present?
"According to the info on clinicaltrials.gov, this research is actively seeking volunteers and was first advertised on February 9th 2023, with its final edit recorded as January 30th 2023."
Answered by AI
Has the government's regulatory agency sanctioned MK-2060 for medicinal use?
"As MK-2060 is currently in its initial phase of testing, our team at Power has graded its safety with a 1. As such, there are only limited sets of data that can support the drug's efficacy and safety."
Answered by AI
How many participants are being admitted to this clinical trial?
"Affirmative. According to the clinicaltrials.gov portal, this medical research project is currently recruiting participants who were initially made aware of it on February 9th 2023 and last updated information was posted January 30th 2023. 12 patients need to be recruited from 2 trial sites."
Answered by AI
Am I qualified to participate in this experiment?
"12 individuals with chronic renal failure aged between 18-80 can join this medical trial, provided they meet the following criteria: A BMI of 18 to 45 kg/m^2 and a stage 4 diagnosis at screening."
Answered by AI
Who else is applying?
What site did they apply to?
Genesis Clinical Research, LLC ( Site 0004)
What portion of applicants met pre-screening criteria?
Did not meet criteria
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