EUCTR2020-004101-32-IT进行中（未招募）1 期
A Phase 2b Multicentre, Randomised, Double-Blind, PlaceboControlled, 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of CKD, defined as:
- •(a) Part A: eGFR (CKD-EPI) >= 30 and <= 60 mL/min/1.73 m2
- •Part B, if safety data from Part A allow (otherwise same as in Part A):
- •(CKD-EPI) >= 20 and <= 60 mL/min/1.73 m2
- •2. Urine albumin to creatinine ratio (UACR) >= 200 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. On a stable dose of ACEi and/or ARB (>= 4 weeks before screening).
- •5. No current or prior treatment within 3 months prior to screening with cytotoxic therapy,
- •immunosuppressive therapy or other immunotherapy.
- •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.
- •PLEASE REFER TO THE PROTOCOL FOR FURTHER INCLUSION CRITERIA
- •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 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 330
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, or anatomical causes of CKD.
- •2 History of epilepsy syndrome.
- •3 Participants with NYHA functional HF class III or IV.
- •4 Acute coronary syndrome (ACS) events within 3 months prior to screening.
- •5 Participants with a confirmed BNP >= 200 pg/mL or BNP >= 400 pg/mL if with atrial fibrillation.
- •6 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.
- •7 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 (ie, chemotherapy, infective myocarditis, septic cardiomyopathy).
- •8 High output HF (eg, due to hyperthyroidism or Paget's disease).
- •9 Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
- •10 Participants with uncontrolled diabetes mellitus (HbA1c > 12%).
- •PLEASE REFER TO THE PROTOCOL FOR FURTHER EXCLUSION CRITERIA
研究者
相似试验
进行中（未招募）
1 期
Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)Chronic Kidney DiseaseEUCTR2020-004101-32-NLAstraZeneca495
进行中（未招募）
1 期
Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersChronic Kidney DiseaseEUCTR2020-004101-32-HUAstraZeneca594
进行中（未招募）
1 期
Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersChronic Kidney DiseaseEUCTR2020-004101-32-BGAstraZeneca495
进行中（未招募）
1 期
Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersChronic Kidney DiseaseEUCTR2020-004101-32-SKAstraZeneca AB495
进行中（未招募）
1 期
Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersChronic Kidney DiseaseEUCTR2020-004101-32-ESAstraZeneca660