BridgeMD
Albuminuria Reduction Trial and Investigation with Survodutide Treatment in CKD (ARTIST-CKD)
EU CTIS ID: 2025-525068-13-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.