CTIS2023-506434-69-00进行中（未招募）1 期
FINESSE; Optimization of albuminuria lowering therapies to individual patients with CKD using FINErenone and SEmaglutide (FINESSE-CKD) - 17456
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •Age = 18 years, Urinary albumin to creatinine ratio =100 mg/g and =3500 mg/g, eGFR =25 and =90 mL/min/1.73m2, HbA1c =5.7% and <11%, On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated, On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated, Willing to sign an informed consent
排除标准
- •Diagnosis of type 1 diabetes, History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator’s assessment., History of noncompliance to medical regimens or unwillingness to comply with the study protocol., Heart Failure NYHA Class II to IV requiring MRA treatment, Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study., Women of childbearing potential (WOCBP): WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized; WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening., Acute coronary syndrome event within 6 months, Serum potassium > 5.0 mmol/L, Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt, Active pregnancy or breastfeeding, History of kidney or liver transplant, History of chronic pancreatitis or idiopathic acute pancreatitis, Active malignancy, Suggestive evidence of adrenal insufficiency, Heart Failure with reduced ejection fraction, Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements., Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma, Personal history of non-familial medullary thyroid carcinoma, History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA, Uncontrolled arterial hypertension (mean sitting systolic blood pressure (SBP) =180 mmHg or diastolic blood pressure (DBP) =110 mmHg), Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the 6 months; Major gastrointestinal tract surgery as determined by the physician; Pancreatitis within 6 months. GI ulcers and/or bleeding within 6 months; Evidence of urinary obstruction or difficulty in voiding at screening., Participation in any clinical trial within 3 months prior to initial dosing., Donation or loss of ?400 ml blood within 8 weeks prior to initial dosing.
研究者
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