Two drugs, one goal: can finerenone or semaglutide cut kidney damage markers?
NCT ID NCT07819227
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing whether finerenone, semaglutide, or the two together can lower albuminuria, a marker of kidney damage, in adults with chronic kidney disease. About 41 participants receive each treatment in turn, with urine protein measured throughout. The trial also checks whether people can collect urine samples at home instead of at a clinic. The goal is to learn which drug works best for each individual.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- finerenone and semaglutide, tested alone and in combination
- What this could lead to
- If the approach works, doctors could match each person with CKD to the drug that lowers their urine protein the most, and home urine testing might make that monitoring easier.
- What could go wrong
- This is a small Phase 2 trial of about 41 people, so any signal may not hold in larger groups. Both drugs can cause side effects, and a 40-week crossover cannot show whether either treatment protects kidneys over years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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41 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g * eGFR ≥25 and ≤90 mL/min/1.73m2 * HbA1c ≥5.7 and ≤11% * On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated * On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated * Willing to sign an informed consent Exclusion Criteria: * Diagnosis of type 1 diabetes * Heart Failure with reduced ejection fraction and NYHA Class II to IV * Acute coronary syndrome event within 6 months * Serum potassium \> 5.0 mmol/L * 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 * History of chronic pancreatitis or idiopathic acute pancreatitis * Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma * Personal history of non-familial medullary thyroid carcinoma * History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA * Uncontrolled arterial hypertension (mean sitting 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. * Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements. * 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):15 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital University Clinica Incliva
Valencia, Spain
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Hospital Vall d'Hebron
Barcelona, Spain
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Steno Diabetes Center
Copenhagen, Denmark
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University of Calabria
Cosenza, Italy
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University of Campania
Naples, Italy
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Ziekenhuisgroep Twente
Almelo, Netherlands
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