NCT07107945招募中3 期
A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 215
- 主要终点
- Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
研究概览
简要总结
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.
Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.
Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity).
- •Age 2 to 17 years at screening Visit
- •Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to <90 mL/min/1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg/g
- •Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial.
- •Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial.
- •Further inclusion criteria apply.
排除标准
- •Confirmed type 1 or type 2 diabetes mellitus.
- •History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation.
- •Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.
- •Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion).
- •Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit
- •Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.
- •Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit
- •Severe, uncontrolled hypertension (based on investigator's judgement).
- •Further exclusion criteria apply.
研究组 & 干预措施
Placebo arm
Placebo Comparator
干预措施: Placebo (Drug)
Empagliflozin treatment arm
Experimental
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
时间窗: Up to week 24
Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]
时间窗: Up to week 24
次要结局
- Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin(Up to week 73)
- Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin(Up to week 73)
- Annual rate of change in eGFR (U25Crea) from the Week 8 to the Week 24 visit, including treatment effect extrapolation from (adult) EMPA-KIDNEY data(Up to week 24)
- Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR)(Up to week 24)
- The observed predose plasma concentrations of empagliflozin at the Week 26 visit(Up to week 26)
- Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP)(Up to week 73)
研究者
研究点 (215)
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