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MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis
EU CTIS ID: 2024-511055-17-00
What this study is testing
1.To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Current diagnosis of ESRD.
- Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization
- A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.
You likely can't join if
- Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
- Mechanical/prosthetic heart valve.
- Recent hemorrhagic stroke or lacunar stroke (<1 month).
- Recent evidence (<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
- Recent history (<1 year) of drug or alcohol abuse or dependence.
- Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
See the full eligibility criteria
- Current diagnosis of ESRD.
- Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization
- A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.
- Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
- Mechanical/prosthetic heart valve.
- Recent hemorrhagic stroke or lacunar stroke (<1 month).
- Recent evidence (<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
- Recent history (<1 year) of drug or alcohol abuse or dependence.
- Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
- Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
- Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Puerto Rico
- Argentina
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Puerto Rico; Argentina; Brazil; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.