Albuminuria Reduction Trial and Investigation with Survodutide Treatment in CKD (ARTIST-CKD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boehringer Ingelheim

External identifiers

EU CT number

2025-525068-13-00

ClinicalTrials.gov

NCT07206290

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 8

1. To study the effect of survodutide versus placebo on eGFR (creatinine, cystatin C, and creatinine-cystatin C)
2. To study the effect of survodutide versus placebo on Iohexol measured GFR (subset of 60 participants)
3. To study the effect of survodutide versus placebo on change in UACR and eGFR during 4-week wash-out from week 36 to 40
4. To study the effect of survodutide versus placebo on perirenal and renal sinus fat measured by MRI (same subset of 60 participants with Iohexol GFR)
5. To study the effect of survodutide versus placebo on subcutaneous and visceral fat assessed by MRI (same subset of 60 participants with Iohexol GFR)
6. To study the effect of survodutide versus placebo on body weight
7. To study the effect of survodutide versus placebo on waist circumference
8. To study the effect of survodutide versus placebo on systolic and diastolic blood pressure

Conditions and MedDRA coding

Chronic Kidney Disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 18 years
2. eGFR ≥ 20 and <90 mL/min/1.73m2
3. Urinary albumin to creatinine ratio ≥30 mg/g and <3500 mg/g
4. BMI ≥ 23 kg/m2 (with participants with BMI ≥23 to <25 capped at 10% of the total study population)
5. Stable kidney function (no more than 30% change in eGFR in the 3 months prior to enrolment)
6. On a stable maximum tolerated dose of an ACEi/ARB for at least 4 weeks prior to enrolment
7. If using an SGLT2 inhibitor, receiving a stable dose for at least 8 weeks prior to enrolment
8. Willing to sign an informed consent
9. If using an MRA, receiving a stable dose for at least 8 weeks prior to enrolment

Exclusion criteria 28

1. Diagnosis of type 1 diabetes
2. 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
3. Active pregnancy or breastfeeding
4. History of kidney or liver transplant
5. Active malignancy
6. Suggestive evidence of adrenal insufficiency
7. A history of acute pancreatitis
8. 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
9. Participation in any clinical trial within 3 months prior to initial dosing
10. Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing
11. 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
12. History of chronic pancreatitis or idiopathic acute pancreatitis
13. History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
14. 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
15. 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
16. Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)
17. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
18. Calcitonin levels ≥100 pg/mL or 29.26 pmol/L
19. Personal history of non-familial medullary thyroid carcinoma
20. History of severe hypersensitivity or contraindications to any glucagon RA or GLP-1 RA
21. Uncontrolled arterial hypertension (mean semi supine systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
22. Cardiovascular event within 3 months prior to enrolment
23. Treatment with GLP-1RA for <12 weeks prior to screening
24. 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
25. Elevation of serum lipase (>3 x ULN)
26. HbA1c > 10.5%
27. Uncontrolled unstable diabetic retinopathy or maculopathy
28. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change from baseline to week 32/36 in first morning void UACR

Secondary endpoints 8

1. Change from baseline to week 36 in eGFR (creatinine, cystatin C, and creatinine-cystatin C)
2. Change from baseline to week 36 in Iohexol measured GFR (subset of 60 participants)
3. Change in UACR and eGFR during 4-week wash-out from week 36 to 40
4. Change from baseline to week 36 in Perirenal and renal sinus fat measured by MRI (same subset of 60 participants with Iohexol GFR)
5. Change from baseline to week 36 in Subcutaneous and visceral fat assessed by MRI (same subset of 60 participants with Iohexol GFR)
6. Change from baseline to week 36 in Body weight
7. Change from baseline to week 36 in Waist circumference
8. Change from baseline to week 36 in Systolic and diastolic blood pressure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Hiddo Lambers Heerspink

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Hiddo Lambers Heerspink

Locations

3 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications