EUCTR2020-004101-32-HU进行中（未招募）1 期
A Phase 2b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) = 20 mL/min/1.73 m2 - Zenith-CKD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 594
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Type of Participant and Disease Characteristics / Laboratory Parameters
- •Diagnosis of CKD, defined as:
- •1. eGFR (CKD-EPI) = 20 mL/min/1.73 m2
- •2. Urine albumin to creatinine ratio (UACR) = 150 and = 5000 mg albumin/g creatinine, based on a single first morning void spot urine sample at screening
- •Medical Treatment
- •3 No current or prior (within 1 month of screening) medical treatment with an SGLT2i or any FDC with SGLT2i (such as SGLT2i + metformin).
- •4 If ACEi and/or ARB are prescribed, the dose must be stable = 4 weeks before screening. Participants who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications can be enrolled.
- •5 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.
- •6 Body mass index (BMI) = 40 kg/m2 .
- •7 Male or female of non-childbearing potential.
- •Reproduction
- •8 Female participants must have a negative pregnancy test at screening, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- •(a) Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH and LH levels in the postmenopausal range.
- •(b) Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
- •9 Male participants must be surgically sterile, abstinent, or in conjunction with a female sexual partner, using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of investigational product to prevent any pregnancies. Male study participants must not donate or bank sperm during this same time period.
- •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 297
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 297
排除标准
- •1 Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease
- •2 Participants with NYHA functional HF class III or IV
- •3 Acute coronary syndrome (ACS) events within 3 months prior to screening
- •4 Participants with a BNP = 200 pg/mL or NT proBNP = 600 pg/mL if with atrial fibrillation (NP = 400 pg/mL respective NT proBNP = 1200 pg/mL if associated with atrial fibrillation) measured by local laboratory at screening (Visit 1).
- •5 Participants with unstable HF requiring hospitalisation for optimization of HF treatment and/or who have not been stable on HF therapy within 6 months prior to screening.
- •6 Heart failure due to cardiomyopathies that would primarily require other specific 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 (ie, chemotherapy, infective myocarditis, septic cardiomyopathy).
- •7 High output HF (eg, due to hyperthyroidism or Paget's disease).
- •8 Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
- •9 Participants with uncontrolled diabetes mellitus (HbA1c > 12%).
- •10 Participants with T1DM.
- •11 Hyponatremia, defined as serum Na+ < 135 mmol/L at the time of screening (Visit 1).
- •12 Intermittent or persistent second or third degree atrioventricular(AV) block after sinus node dysfunction, with clinically significant bradycardia or sinus pause when not treated with pacemaker.
- •13 Prolonged QT interval (QTcF > 470ms) on ECG at screening (Visit 1) or randomisation visit (Visit 2), known congenital long QT syndrome or history of QTprolongation associated with other medications.
- •14 History of any life-threatening cardiac dysrhythmia (continuous or paroxysmal or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter).
- •15 Cardiac surgery or non-elective percutaneous coronary interventions (PCI/TAVI) (within 3 months) or open chest coronary artery bypass grafting or valvular repair/replacement (within 3 months) prior to screening or is planned to undergo any of these procedures after randomisation.
- •16 Heart transplantation or left ventricular assist device at any time.
- •17 Kidney or any organ transplantation.
- •18 History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or drugs with a similar chemical structure to zibotentan.
- •19 Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, as judged by the investigator, 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:
- •(a) Isolated pulmonary arterial hypertension (defined as mean PAP = 25 mmHg at rest)
- •or right ventricular failure; in the absence of left-sided HF.
- •(b) Anaemia defined as haemoglobin (Hb) level < 100 g/L or 10 g/dL at screening (Visit 1).
- •(c) Severe chronic obstructive pulmonary disease (COPD) or other lung disease including but not limited to p
研究者
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