NL-OMON52170已完成2 期
A Phase 2b Multicentre, Randomised, Double-Blind, Active 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) Between 20 and 60 mL/min/1.73 m2 - Zenith-CKD
Astra Zeneca0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply:
- •1 Participant must be 18 years of age or older at the time of signing the
- •informed consent.
- •Type of Participant and Disease Characteristics / Laboratory Parameters
- •2 Diagnosis of CKD, defined as:
- •(a) eGFR (CKD-EPI) >= 20 mL/min/1.73 m2 (by CKD-EPI formula, see Section 8.1.2.2)
- •(b) 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
- •any FDC with SGLT2i (such as SGLT2i + metformin).
- •4 If ACEi and/or ARB and/or MRA are prescribed, the dose must be stable >= 4
- •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
- •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
- •cessation of all exogenous hormonal treatments and FSH and LH levels in the
- •postmenopausal range.
- •(b) Documentation of irreversible surgical sterilisation by hysterectomy,
- •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 (see
- •Section 8.3.8.2).
- •Methods that can achieve a failure rate of less than 1% per year when used
- •consistently and correctly are considered highly effective birth control
- •methods such as:
- •Combined (oestrogen and progesterone containing) hormonal contraception
- •with inhibition of ovulation:
- •* Intravaginal.
- •* Transdermal.
- •Progesterone-only hormonal contraception associated with inhibition of
- •* Injectable.
- •* Implantable.
- •Intrauterine device (IUD).
- •Intrauterine hormone-releasing system (IUS).
- 另有 10 项未显示
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •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 (BNP >= 400 pg/mL
- •or NT-proBNP >= 1200 pg/mL, respectively, if associated with atrial
- •fibrillation) measured by local laboratory at screening (Visit 1).
- •5 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
- •6 Heart failure due to cardiomyopathies that would primarily require 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 (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 QT
- •prolongation 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
- 另有 9 项未显示
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