NCT07206290尚未招募2 期
Albuminuria Reduction Trial and Investigation With Survodutide Treatment in CKD
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change in first morning void UACR
研究概览
简要总结
The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •eGFR ≥20 and <90 mL/min/1.73m2
- •Urinary albumin to creatinine ratio >30 mg/g and <3500 mg/g
- •BMI >21 kg/m2
- •Stable kidney function (no more than 30% change in eGFR in the 3 months prior to enrolment)
- •On a stable maximum tolerated dose of an ACEi/ARB for at least 4 weeks prior to enrolment
- •If using an SGLT2 inhibitor, receiving a stable dose for at least 8 weeks prior to enrolment
- •Willing to sign an informed consent
排除标准
- •Diagnosis of type 1 diabetes
- •Cardiovascular event within 3 months prior to enrolment
- •Treatment with GLP-1RA for <12 weeks prior to screening
- •Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;
- •Active pregnancy or breastfeeding
- •History of kidney or liver transplant
- •Active malignancy
- •Suggestive evidence of adrenal insufficiency
- •Acute pancreatitis <180 days prior to screening
- •History of chronic pancreatitis or idiopathic acute pancreatitisPersonal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
- •Calcitonin levels ≥100 pg/mL or 29.26 pmol/L
- •Personal history of non-familial medullary thyroid carcinoma
- •History of severe hypersensitivity or contraindications to any glucagon RA or GLP-1 RA
- •Uncontrolled arterial hypertension (mean semi supine systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
- •Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •History of active inflammatory bowel disease within the 6 months;
- •Major gastrointestinal tract surgery as determined by the physician;
- •Pancreatitis within 6 months.
- •GI ulcers and/or bleeding within 6 months;
- •Evidence of urinary obstruction or difficulty in voiding at screening.
- •Participation in any clinical trial within 3 months prior to initial dosing.
- •Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.
- •History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator's assessment.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •Women of childbearing potential (WOCBP):
- •WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
- •WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.
- •Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)
研究组 & 干预措施
Survodutide
Experimental
2:1 fashion to a 16 weeks up-titration phase of survodutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg and 3.6 mg subcutaneous injection weekly) followed by a 20 weeks maintenance phase of survodutide s.c. 3.6 mg once weekly
干预措施: Survodutide (BI 456906) (Drug)
Placebo
Placebo Comparator
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in first morning void UACR
时间窗: From baseline to week 32/36
Average of first morning void urine samples collected at week 32 and 36 will be used to decrease random day-to-day variability and increase precision (and statistical power).
次要结局
- eGFR (creatinine, cystatin C, and creatinine-cystatin C)(From baseline to week 36)
- Iohexol measured GFR(From baseline to week 36)
- UACR and eGFR during 4-week wash-out(From week 36 to 40)
- Perirenal and renal sinus fat measured by MRI(From baseline to week 36)
- Subcutaneous and visceral fat assessed by MRI(From baseline to week 36)
- Body weight(From baseline to week 36)
- Waist circumference(From baseline to week 36)
- Systolic and diastolic blood pressure(From baseline to week 36)
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