Current partner codePEPTIDESDE
NCT07206290·Phase 2·INTERVENTIONAL

Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Status

Not yet recruiting

Phase

Phase 2

Enrollment

120

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Survodutide (BI 456906)

0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, 3.6 mg s.c. weekly

DRUG

Placebo

Placebo matching survodutide

Timeline

From registration to results.

  1. First posted

    Oct 3, 2025

  2. Study start

    Mar 2, 2026

  3. Primary completion

    Nov 30, 2027

  4. Study completion

    Nov 30, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Oct 3, 2025

Outcomes

What the study measures.

Primary outcomes

Change in first morning void UACR

Time frame · 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).

Secondary outcomes

eGFR (creatinine, cystatin C, and creatinine-cystatin C)

Time frame · From baseline to week 36

Iohexol measured GFR

Time frame · From baseline to week 36

Subset of 60 participants

UACR and eGFR during 4-week wash-out

Time frame · From week 36 to 40

Perirenal and renal sinus fat measured by MRI

Time frame · From baseline to week 36

Same subset of 60 participants with Iohexol GFR

Subcutaneous and visceral fat assessed by MRI

Time frame · From baseline to week 36

Same subset of 60 participants with Iohexol GFR

Body weight

Time frame · From baseline to week 36

Waist circumference

Time frame · From baseline to week 36

Systolic and diastolic blood pressure

Time frame · From baseline to week 36

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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)

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.