NCT06954090

Brief Summary

Title: Body fluid proteome SIGnatures for persoNALised intervention to prevent cardiovascular and renal complications in diabetes. Aim: To explore the feasibility of using urinary proteomic risk scores in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional renocardiovascular protective treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Nov 2025May 2027

First Submitted

Initial submission to the registry

April 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

December 22, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

April 14, 2025

Last Update Submit

December 15, 2025

Conditions

Type 2 DMType 2 DM /Diabetic NephropathyAlbuminuria

Keywords

urine proteomicsprecision medicineprevention of diabetic complicationspersonalized treatmentbiomarkerCKD273

Outcome Measures

Primary Outcomes (2)

  • Proteomic feasibility

    Achieve urine proteomic results within 2 weeks of sampling for at least 90% of the participants in clinical practice.

    2 weeks from sampling

  • Evaluation of medical treatment

    Ensure that urine proteomic results are interpreted for evaluating medical treatment in at least 90% of participants.

    3 weeks from sampling

Secondary Outcomes (2)

  • Urine Albumin-to-Creatinine Ratio

    Over the 6 month of the follow up from screening visit to the end of study.

  • Urinary proteomic signatures

    Over the 6 month of the follow up from screening visit to the end of study.

Other Outcomes (1)

  • Assessment of health economics

    6 months from all participent data is collected

Study Arms (3)

Semaglutide

ACTIVE COMPARATOR

3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated.

Drug: Semaglutide, 1.34 mg/mL

Finerenone

ACTIVE COMPARATOR

3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated.

Drug: Finerenone Oral Tablet

Dapagliflozin

ACTIVE COMPARATOR

3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated.

Drug: Dapagliflozin (DAPA)

Interventions

Semaglutide, 1.34 mg/mLDRUG

Semaglutide will be introduced at a dose of 0.25 mg/week subcutaneous injection, escalated to 0.5 and 1.0 mg/week after 4 and 8 weeks if tolerated.

Also known as: Ozempic
Semaglutide
Finerenone Oral TabletDRUG

Finerenone will be introduced at a dose of 10 mg/day in patients with a serum potassium level \< 4.8 mmol/l and eGFR \< 60 ml/min/1.73 m2 and escalated to 20 mg/day after 4 weeks if the serum potassium level is still \< 4.8 mmol/l. Starting dose is 20 mg/day if eGFR ≥ 60 ml/min/1.73 m2. The dosage will be reduced or discontinued in patients who develop hyperkalemia (serum potassium \> 5.5 mmol/l).

Finerenone
Dapagliflozin (DAPA)DRUG

Dapagliflozin will be introduced at a dose of 10 mg/day. The dose can be reduced at any time during the trial if required by the subject's tolerance to the product.

Dapagliflozin

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsEligibility for this study is based on gender identity, not biological sex. This means that the study is open to anyone who identifies as male or female, regardless of their biological sex. We recognize and respect each person's gender identity, and eligibility is determined by how they identify.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 18 years of age.
  • Type 2 diabetes with no clinical signs of HF NYHA Class IV
  • Able to understand the written participant information and give informed consent.

You may not qualify if:

  • Heart failure NYHA class IV at screening
  • Moderately - or severely increased albuminuria with a UACR ≥ 200 mg/g or CKD with an eGFR \< 30 ml/min/1.73m2 at the screening visit.
  • A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
  • Receiving therapy with all three of the study medication prior to enrolment.
  • Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
  • Known or suspected hypersensitivity to the study medications or related products
  • History of pancreatitis at the screening visit
  • Body mass index \< 18.5 kg/m2 at the screening visit
  • Type 1 diabetes
  • Serum potassium \> 5.0 mmol/L at the screening visit
  • Addison's Disease
  • Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone)
  • Treatment with a potassium-sparing diuretic (amiloride, triamterene)
  • Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone)
  • Elevated Alanine Aminotransferase (ALT) \> 3x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of oesophageal varices or a history of portocaval shunt.)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Hajdú-Bihar, 2730, Denmark

Location

MeSH Terms

Conditions

Albuminuria

Interventions

semaglutidefinerenonedapagliflozin

Condition Hierarchy (Ancestors)

ProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Rossing, Clinical Professor

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Low intervention feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 1, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

December 22, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)