JPRN-jRCT2041200106进行中（未招募）2 期
The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) 20 mL/min/1.73 m^2 or more, and urinary albumin to creatinine ratio (UACR) 150 mg/g or more and 5000 mg/g or less. - ZENITH-CKD
Ageishi Yuji0 个研究点目标入组 660 人开始时间: 2021年3月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Diagnosis of CKD, defined as:
- •(a) eGFR chronic kidney disease epidemiology collaboration (CKD-EPI) 20 mL/min/1.73 m^2 or more, and
- •(b) UACR 150 or more and 5000 mg or less albumin/g creatinine, based on a single first morning void spot urine sample at screening.
- •- No current or prior (within 1 month of screening) medical treatment with an SGLT2i (sodium-glucose co-transporter 2 inhibitor) or any fixed dose combination with SGLT2i
- •- If ACEi and/or ARB and/or mineralocorticoid receptor agonist (MRA) are prescribed, the dose must be stable 4 weeks or more before screening. Participants who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications can be enrolled
- •- No current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary kidney disease
- •- Body mass index (BMI) 40 kg/m^2 or less
- •- All participants should follow protocol defined contraceptives procedures
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease.
- •- Participants with New York Heart Association classification functional heart failure (HF) class III or IV
- •- Acute coronary syndrome events within 3 months prior to screening
- •- Participants with a confirmed B-type natriuretic peptide (BNP) 200 pg/mL or more, or NT-proBNP 600 pg/mL or more (or BNP 400 pg/mL or more or NT-proBNP 1200 pg/mL or more, respectively, if associated with atrial fibrillation measured by local laboratory at screening (Visit 1)
- •- Participants with unstable HF requiring hospitalisation for optimisation of HF treatment and/or who have not been stable on HF therapy within 6 months prior to screening
- •- Heart failure due to cardiomyopathies that would primarily require specific other treatment: eg, cardiomyopathy due to pericardial disease, amyloidosis or other infiltrative diseases, cardiomyopathy related to congenital heart disease, primary hypertrophic cardiomyopathy, cardiomyopathy related to toxic or infective conditions
- •- High output HF
- •- Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement
- •- Participants with uncontrolled diabetes mellitus (HbA1c > 12%), and with T1DM
- •- Intermittent or persistent second or third degree atrioventricular block after sinus node dysfunction, with clinically significant bradycardia or sinus pause when not treated with pacemaker
- •- History of any life-threatening cardiac dysrhythmia
- •- Cardiac surgery or non-elective percutaneous coronary interventions (within 3 months) or open chest coronary artery bypass grafting or valvular repair/replacement (within 12 months) prior to screening or is planned to undergo any of these procedures after randomisation
- •- Heart transplantation or left ventricular assist device at any time
- •- History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i or drugs with a similar chemical structure to zibotentan
- •- Any clinically significant disease or disorder, which might put the participant at risk because of participation in the study, or probable alternative primary reason for participant's symptoms in judgment of investigator, including but not limited to:
- •_ Isolated pulmonary arterial hypertension (defined as mean PAP 25 mmHg or more at rest) or right ventricular failure; in the absence of left-sided HF
- •_ Anaemia defined as haemoglobin (Hb) level < 100 g/L or 10 g/dL at screening (Visit 1)
- •_ Severe chronic obstructive pulmonary disease or other lung disease including but not limited to pulmonary fibrosis requiring chronic oxygen therapy, regular nebuliser use, or oral steroid therapy
- •- Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within previous 3 months prior to screening Severe hepatic impairment (Child-Pugh class C Hepatic impairment), aspartate transaminase or alanine transaminase > 2x the upper limit of normal [ULN]; or total bilirubin > 2x ULN at time of screening
- •- Participants with newly detected pathological laboratory values or an ongoing disease condition requiring investigation and/or initiation or adjustment of current treatment
- •- Positive hepatitis C antibody, or hepatitis
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