A global trial to evaluate the efficacy and safety of MK-2060 in patients with end stage renal disease receiving hemodialysis
- Conditions
- Prevention of arteriovenous graft thrombosis in patients with end stage renal disease receiving hemodialysis.MedDRA version: 20.1Level: PTClassification code 10053182Term: Arteriovenous graft thrombosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2020-002397-27-BG
- Lead Sponsor
- Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 489
1. Has a current diagnosis of ESRD.
2. Has been receiving hemodialysis (including hemodiafiltration)
prescribed =3 times per week for a minimum of 3 hours per session via mature normally functioning (spKt/V .1.2), uninfected AVG. Criterion must be met for at least 75% of the sessions over the 4 weeks prior to randomization.
3. Is male or female, =18 years of age inclusive, at the time of providing documented informed consent.
4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a WOCBP
OR
Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 90 days, corresponding to the time needed to eliminate any study intervention (eg, 5 terminal half-lives) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (serum) within 6 days before the first dose of study intervention.
The participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
5. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 269
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
1. Has a recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
2. Has a mechanical/prosthetic heart valve.
3. Had a recent hemorrhagic stroke or lacunar stroke (<1 month).
4. Had recent evidence of bleeding requiring hospitalization or unplanned medical attention (<1 month), a history (=2 years) of recurrent bleeding episodes including epistaxis, GI bleeds or GU bleeds requiring medical treatment or events requiring treatment with blood products.
5. Has a recent history of drug or alcohol abuse or dependence (<1 year).
6. Life expectancy <12 months.
7. Is currently receiving or planning to receive anticoagulants or antiplatelet medications (Individuals that plan to be on low dose aspirin (up to 150 mg per day) during the study or require intradialytic heparin, are permitted in the study).
Prohibited Medications:
- Oral Anticoagulants: Warfarin, Apixaban, Dabigatran, Rivaroxaban, Edoxaban, Betrixaban.
- IV/SC Anticoagulants: IV/SC Heparin and LMWH, IV Warfarin, IV Argatroban, IV Bivalirudin, IV Lepirudin, SC fondaparinux, IV antithrombin III.
- Antiplatelet Medications (P2Y12 inhibitor use is excluded): Aspirin in
doses >150 mg per day (regular use), Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine.
- NSAIDs (eg, ibuprofen); topical NSAIDs are permitted.
8. Has participated in another investigational study within 4 weeks (or 5 half-lives of the investigational drug), whichever is greater, prior to the Screening Visit. The window will be derived from the date of the last use of study treatment in the previous study.
9. Has abnormal coagulation laboratory results including INR >2.0 and/or PT or aPTT >20% above the normal range.
10. Has thrombocytopenia (platelet count <50,000/µL).
11. Has documented severe hypertension (SBP >200 mmHg or DBP >110 mmHg predialysis) at screening or randomization.
12. Is planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
13. Is planning on receiving an AVF placement within 12 months.
14. Is planning non-urgent invasive dental surgeries that are liable for significant blood loss within 12 months.
15. Has had a hypersensitivity reaction to any component of MK-2060 drug product.
16. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.;Secondary Objective: 1. To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to each arteriovenous graft thrombosis event (first and recurrent).<br>2. To assess the safety and tolerability of MK-2060.<br>;Primary end point(s): Time to First Arteriovenous Graft (AVG) Thrombosis Event;Timepoint(s) of evaluation of this end point: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Time to Each Arteriovenous Graft Thrombosis Event (First and<br>Recurrent)<br>2. Number of Participants who Experience One or More Adverse Events (AEs)<br>3. Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria<br>4. Number of Participants Who Discontinue Study Intervention Due to Adverse Event (AE);Timepoint(s) of evaluation of this end point: 1. Up to approximately 34 months<br>2. Up to approximately 37 months <br>3. Up to approximately 37 months<br>4. Up to approximately 34 months<br>