A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery - 24-ROS-07

Guard Therapeutics International AB (publ)0 个研究点目标入组 180 人开始时间: 2024年4月24日最近更新: 2024年8月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Guard Therapeutics International AB (publ)
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: 18 至 65+（—）
性别: All

入选标准

•1. Age is =18 and <85 years at the time of signing the informed consent., 2. eGFR is =30 ml/min/1.73m2 (at screening) using the CKD-EPI 2021 equation with SCr., 3. Scheduled for non-emergent surgery of any or several of the following types with use of CPB: a. CABG surgery b. Valve surgery (single or multiple valves) c. Ascending aorta aneurysm surgery, 4. Risk factors for kidney injury are present (at screening) as specified below: a. eGFR is <60 mL/min/1.73m2 b. If eGFR is =60 mL/min/1.73m2 i. A combined surgery is scheduled AND at least one risk factor for kidney injury from list (1) to (8) below is present. ii. One type of surgery is scheduled AND at least two risk factors for kidney injury from list (1) to (8) below are present. Risk factors for AKI: (1) Documented history of LVEF <35% at any time during the 3-month period before or at the time of screening as assessed by either echocardiography, cardiac MRI or nuclear scan. (2) Repeat surgery/history of previous open chest cavity cardiac surgery with or without CPB. (3) Confirmed diagnosis of T2DM at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug. (4) Age =70 years at the time of screening. (5) Documented history of NYHA class II or higher at any time during the 3-month period before or at the time of screening (6) Documented history of AKI as per KDIGO criteria longer than 3 months before date of screening, independent of the etiology of AKI. (7) Documented history of anemia with hemoglobin =11 g/dL at any time during the 3-month period before or at the time of screening. (8) Documented history of albuminuria, defined as urine albumin-to-creatinine ratio (UACR) >100 mg/g in a spot urine sample or >100 mg/24 hour in a 24-hour urine collection at any time during the 3-month period before or at the time of screening., 5. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a WONCBP as defined in the protocol. - Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency, as described in the protocol. A female participant is eligible to participate if she agrees not to donate ova during the study intervention period and for at least 7 days after the last dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (serum) within 48 hours before the first dose of study intervention. Additional requirements for pregnancy testing during and after study intervention are located in the protocol. 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., 6. Male Participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 7 days after the last dose of study intervention: a. Refrain from donating fresh unwashed semen. b. And either (i) or (ii) below: i. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. ii. Must agree to use contraception/barrier as detailed below: - Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective met

排除标准

•1. Any medical condition that in the opinion of the investigator makes the participant unsuitable for study participation. This includes participants unable to give their informed consent., 10. ALT or AST =3.0 x ULN., 11. Total bilirubin =2.0 xULN (Participants with Gilbert’s syndrome can be included with total bilirubin =1.5 x ULN as long as direct bilirubin is < 1.5 x ULN)., 12. History of solid organ transplantation., 13. History of Renal Replacement Therapy., 14. Severe allergic asthma defined as confirmed diagnosis of asthma poorly controlled while receiving high-dose inhaled corticosteroid treatment, or with requirement of a high level of treatment to maintain control., 15. Chronic immunosuppressive treatment that may have an impact on kidney function as assessed by the medical monitor., 16. Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function as assessed by the medical monitor., 17. Current enrolment or past participation within the last 90 days (or within 5 half-lives of an investigational study treatment, whichever is longer) before signing of consent in any other clinical study involving an investigational study treatment., 18. Has previously received RMC-035., 19. Hypersensitivity to any of the study interventions, or components thereof including excipients, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study., 2. Scheduled for emergent surgeries (eg, aortic dissection)., 3. Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries (eg, congenital heart defects). Scheduled additional left atrial appendage closure surgery or maze surgery is not an exclusion criterion., 4. Scheduled to undergo TAVI or TAVR, or off-pump surgeries or LVAD implantation., 5. Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as IABP within 24 hours prior to surgery., 6. Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of MCS., 7. Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery., 8. Requires cardiopulmonary resuscitation within 14 days prior to cardiac surgery., 9. Ongoing sepsis (as defined in the protocol) within the past 2 weeks or, in the opinion of the investigator, an untreated diagnosed clinically significant infection (viral or bacterial) prior to or at screening and before randomization.

研究者

发起方

Guard Therapeutics International AB (publ)

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