2025-525068-13-00招募中2 期
Albuminuria Reduction Trial and Investigation with Survodutide Treatment in CKD (ARTIST-CKD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 19
- 主要终点
- Percentage change from baseline to week 32/36 in first morning void UACR
研究概览
简要总结
The primary objective of the ARTIST-CKD trial is to evaluate the effect of survodutide 3.6 mg per week on albuminuria in people with CKD, irrespective of the presence or absence of diabetes.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 ≥ 23 kg/m2 (with participants with BMI ≥23 to <25 capped at 10% of the total study population)
- •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
- •If using an MRA, receiving a stable dose for at least 8 weeks prior to enrolment
排除标准
- •Diagnosis of type 1 diabetes
- •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 chronic pancreatitis or idiopathic acute pancreatitis
- •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 without 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)
- •Personal 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
- •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
- •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)
- •Cardiovascular event within 3 months prior to enrolment
- •Treatment with GLP-1RA for <12 weeks prior to screening
- •Use of sensitive CYP3A4 substrates with a narrow therapeutic index (e.g. alfentanil, fentanyl, carbamazepine, cyclosporine, tacrolimus, sirolimus) or use of any GLP-1, GIP/GLP-1 or GIP/GLP-1/glucagon receptor agonist
- •Elevation of serum lipase (>3 x ULN)
- •HbA1c > 10.5%
- •Uncontrolled unstable diabetic retinopathy or maculopathy
- •Additional criteria applicable for sub-set of participants for MRI assessment of perirenal, epicardial, subcutaneous and visceral fat: o Contraindication to MRI including, but not limited to severe claustrophobia, extensive tattoos, inner ear implant, pacemakers incompatible with MRI, other implanted cardiac rhythm management device, intracranial aneurism clips incompatible with MRI, any other metallic, non-MRI compatible implanted devices (e.g. hip replacement), a history of intra-orbital metal fragments that have not been removed, and weight or girth that exceeds scanner capabilities o Participants who do not fulfil the MRI criteria are eligible for the main trial if the eligibility criteria for the main trial are fulfilled.
- •Active pregnancy or breastfeeding
- •History of kidney or liver transplant
- •Active malignancy
- •Suggestive evidence of adrenal insufficiency
- •A history of acute pancreatitis
- •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; A history of pancreatitis; 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
研究组 & 干预措施
BI 456906, BI 456906, BI 456906, BI 456906, BI 456906
Test
干预措施: BI 456906 (Drug)
Matching placebo for Survodutide
Placebo
干预措施: Matching placebo for Survodutide (Drug)
结局指标
主要结局
Percentage change from baseline to week 32/36 in first morning void UACR
Percentage change from baseline to week 32/36 in first morning void UACR
次要结局
- Change from baseline to week 36 in eGFR (creatinine, cystatin C, and creatinine-cystatin C)
- Change from baseline to week 36 in Iohexol measured GFR (subset of 60 participants)
- Change in UACR and eGFR during 4-week wash-out from week 36 to 40
- Change from baseline to week 36 in Perirenal and renal sinus fat measured by MRI (same subset of 60 participants with Iohexol GFR)
- Change from baseline to week 36 in Subcutaneous and visceral fat assessed by MRI (same subset of 60 participants with Iohexol GFR)
- Change from baseline to week 36 in Body weight
- Change from baseline to week 36 in Waist circumference
- Change from baseline to week 36 in Systolic and diastolic blood pressure
研究者
Hiddo Lambers Heerspink
Scientific
Universitair Medisch Centrum Groningen
研究点 (19)
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