Actively Recruiting
A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study
Led by Peter Rossing · Updated on 2025-11-20
125
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peter Rossing
Lead Sponsor
U
University Medical Center Groningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic kidney disease (CKD) affects over 800 million people worldwide and leads to significant health challenges, including multiple secondary diseases, frequent hospital visits, and high costs. Recent advances have identified promising drugs like sodium-glucose co-transporter 2 inhibitors, finerenone, and semaglutide that may slow CKD progression. This study aims to evaluate whether a biomarker-guided treatment approach can better reduce kidney function decline compared to standard care in CKD patients with albuminuria. This prospective, randomized, open-label study plans to enroll 125 participants with CKD and albuminuria who will be randomly assigned to either a biomarker-targeted treatment group or a standard care group. In the treatment group, medications such as dapagliflozin, finerenone, and semaglutide will be added stepwise based on urinary biomarkers (UACR and UEGF) and individual response. After about four weeks on each drug's maximum tolerated dose, biomarker levels will be reassessed to decide whether to continue, switch, or add treatments. Participants will undergo regular evaluations of kidney function through estimated glomerular filtration rate (eGFR) and urinary biomarkers throughout the study, which lasts over two years. The main outcome measured is the change in eGFR slope from week 26 to week 104. Additional assessments include changes in eGFR and UACR from baseline to week 104 or 112. Safety and effectiveness of the biomarker-guided approach will be monitored carefully during the trial.
CONDITIONS
Brief Title
A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Urinary albumin-to-creatinine ratio (UACR) 100-5000 mg/g in two consecutive first-morning urine samples at screening
- Stable treatment with maximum tolerated dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks before randomization, unless not tolerated or contraindicated
- Ability to communicate with study staff and provide informed consent
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m2 at screening
- Current treatment with two or all three study drugs (dapagliflozin, finerenone, semaglutide)
- History of pancreatitis
- Body mass index less than 18.5 kg/m2
- Type 1 diabetes
- Recent myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks
- NYHA class IV congestive heart failure
- Potassium level above 5.0 mmol/L
- Addison's disease
- Use of strong CYP3A4 inhibitors
- Treatment with potassium-sparing diuretics or mineralocorticoid receptor antagonists except finerenone
- Severe liver disease or elevated liver enzymes above 3 times normal
- Polycystic kidney disease
- Lupus nephritis, ANCA-associated vasculitis, or other kidney diseases requiring immunosuppressive therapy within 6 months
- Kidney transplant or dialysis
- Known or suspected allergy to study medications
- History of cancer within five years except certain skin cancers
- Any condition affecting safety or study compliance as judged by investigator
- Pregnancy, breastfeeding, or plans to become pregnant without effective contraception
- Known or suspected narcotics abuse
- Participation in another intervention study
- Mentally incapacitated or under guardianship preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks
Participants receive stepwise treatment with one or more study medications (dapagliflozin, finerenone, and/or semaglutide) based on their characteristics and biomarker responses. Treatment decisions are guided by urinary albumin-to-creatinine ratio (UACR) and urinary epidermal growth factor (UEGF) measurements, with evaluations after approximately four weeks on the maximum tolerated dose of each medication to decide on continuing, switching, or adding treatments.
Multiple visits approximately every 4 weeks for medication evaluation and adjustment
Trial Site Locations
Total: 4 locations
1
Steno Diabetes Center Copenhagen
Herlev, Denmark
Actively Recruiting
2
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Not Yet Recruiting
3
Hospital Clinico de Valencia
Valencia, Spain
Not Yet Recruiting
4
Lund University
Malmö, Sweden
Not Yet Recruiting
Research Team
P
Peter Rossing
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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