Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

NCT07206290 | Not Yet Recruiting Phase 2

• 2 other identifiers: 227742025-523184-37-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in first morning void UACR

  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).

  From baseline to week 32/36

Secondary Outcomes (8)

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

  From baseline to week 36

• Iohexol measured GFR

  From baseline to week 36

• UACR and eGFR during 4-week wash-out

  From week 36 to 40

• Perirenal and renal sinus fat measured by MRI

  From baseline to week 36

• Subcutaneous and visceral fat assessed by MRI

  From baseline to week 36

Other Outcomes (4)

• HbA1c

  From baseline to week 36

• High-sensitivity C-reactive protein

  From baseline to week 36

• NT-proBNP

  From baseline to week 36

Study Arms (2)

Survodutide

EXPERIMENTAL

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

Drug: Survodutide (BI 456906)

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

Survodutide (BI 456906) DRUG

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

Survodutide

Placebo DRUG

Placebo matching survodutide

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 \>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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hiddo J Lambers Heerspink, Prof. Dr.

CONTACT

+31-50-3617859; h.j.lambers.heerspink@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel, randomized, double-blind, placebo-controlled clinical trial conducted in 4 countries (Netherlands, Germany, Spain and Australia)

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share