Phase
Condition
N/ATreatment
Dapagliflozin
Semaglutide
Finerenone
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 and ≤ 75 years
UACR 100-5000 mg/g (11.3-565 mg/mmol) in two consecutive first-morning void urinesamples at screening. (UACR 80-100 mg/g is accepted if historical measurements areabove 100 mg/g and if it cannot be explained by any new treatment.)
Stable treatment with a maximum tolerated dose of an angiotensin-converting enzymeinhibitor or angiotensin receptor blocker for at least four weeks prior torandomization. (Unless such treatment is contraindicated or not tolerated.)
Ability to communicate with the study staff and understand and sign the informedconsent.
Exclusion
Exclusion Criteria:
eGFR < 25 mL/min/1.73m2 at screening.
Treatment with two or all three of the study drugs
History of pancreatitis at screening
Body mass index < 18.5 kg/m2 at screening
Type 1 diabetes
Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
NYHA class IV Congestive Heart Failure at screening
Potassium > 5.0 mmol/L at screening
Addison's Disease
Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole,ketoconazole, ritonavir, cobicistat, clarithromycin)
Treatment with a potassium-sparing diuretic or a mineralocorticoid receptorantagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)
Elevated Alanine Aminotransferase (ALT) > 3 x upper normal limit at screening,autoimmune hepatitis, and/or severe hepatic impairment (including but not limited toa history of hepatic encephalopathy, a history of esophageal varices, or a historyof portocaval shunt).
Autosomal dominant or autosomal recessive polycystic kidney disease
Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondarykidney disease requiring immunosuppressive therapy within 6 months prior toscreening
Kidney transplant or dialysis
Known or suspected hypersensitivity to the study medications or related products
Presence or history of malignant neoplasms (except basal cell skin cancer orsquamous cell skin cancer) within five years before screening.
Any other history, condition, therapy, or uncontrolled intercurrent illness thatcould, as judged by the investigator, affect participant safety or compliance withstudy requirements.
A female who is pregnant, breastfeeding, or intends to become pregnant, or a womanof childbearing potential (WOCBP) who is not using highly effective contraceptivemethods.
Known or suspected abuse of narcotics.
Participant in another intervention study.
Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., notable to understand and sign the informed consent).
Study Design
Study Description
Connect with a study center
Steno Diabetes Center Copenhagen
Herlev 2620431,
DenmarkActive - Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg 2911298,
GermanySite Not Available
Hospital Clinico de Valencia
Valencia 2509954,
SpainSite Not Available
Lund University
Malmo 2692969,
SwedenSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.