Skip to content

Trial · Interventional

Not yet recruitingPhase 2Registry data

Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Short name ARTIST-CKD

NCTNCT07206290 (opens ClinicalTrials.gov in a new tab)Other id22774Other id2025-523184-37-00Other id2025

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
120 participants (estimated)
Sponsor
University Medical Center Groningen · Other
Design
Randomized · Double masking
Countries
Not stated
Start
2 Mar 2026 (estimated)
Primary completion
30 Nov 2027 (estimated)
Completion
30 Nov 2027 (estimated)
First posted
3 Oct 2025
Last update posted
3 Oct 2025
Conditions
Chronic Kidney Disease

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 2

    ARTIST-CKD

    NCT07206290

    est. 2 Mar 2026 to est. 30 Nov 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Survodutide (BI 456906)Drug
  • PlaceboDrug

Arms2

  • Experimental

    Survodutide

    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

  • Placebo comparator

    Placebo

    Matching Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in first morning void UACR

    Time frame · From baseline to week 32/36

    Registry description

    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).

Secondary outcomes(8)
  1. eGFR (creatinine, cystatin C, and creatinine-cystatin C)

    Time frame · From baseline to week 36

  2. Iohexol measured GFR

    Time frame · From baseline to week 36

    Registry description

    Subset of 60 participants

  3. UACR and eGFR during 4-week wash-out

    Time frame · From week 36 to 40

  4. Perirenal and renal sinus fat measured by MRI

    Time frame · From baseline to week 36

    Registry description

    Same subset of 60 participants with Iohexol GFR

  5. Subcutaneous and visceral fat assessed by MRI

    Time frame · From baseline to week 36

    Registry description

    Same subset of 60 participants with Iohexol GFR

  6. Body weight

    Time frame · From baseline to week 36

  7. Waist circumference

    Time frame · From baseline to week 36

  8. Systolic and diastolic blood pressure

    Time frame · From baseline to week 36

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

PepBank is a research reference. Talk to a doctor before you use any peptide.