EUCTR2020-002397-27-PT进行中（未招募）1 期
A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis - MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 489
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Has a current diagnosis of ESRD.
- •2. Has been receiving hemodialysis =3 times per week with each hemodialysis session being a minimum of 3 hours duration via a normally functioning (spKt/V =1.2), uninfected AVG for at least 4 weeks.
- •3. Is male or female, =18 years of age inclusive, at the time of signing the 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
- •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 72 hours 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
排除标准
- •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): Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine.
- •- NSAIDs (eg, ibuprofen); however, the non-NSAID paracetamol/acetaminophen may be used for minor ailments without prior consultation with the Sponsor.
- •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% outside the normal range.
- •10. Has thrombocytopenia (platelet count <50,000/µL).
- •11. Has documented severe hypertension (SBP >200 mmHg or DBP >110 mmHg) 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.
研究者
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