FINESSE: Research on improving albuminuria in patients with chronic kidney disease through the use of finerenone and semaglutide.
- Conditions
- Chronic Kidney DiseaseTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-506434-69-00
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
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
Diagnosis of type 1 diabetes, 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., Heart Failure NYHA Class II to IV requiring MRA treatment, 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): 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., 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, History of chronic pancreatitis or idiopathic acute pancreatitis, Active malignancy, Suggestive evidence of adrenal insufficiency, Heart Failure with reduced ejection fraction, Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements., 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., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate that at least 30% albuminuria reduction can be achieved in a substantial proportion of patients with a single drug (MRA finerenone or GLP1-RA semaglutide) when the best drug for each patient is selected.;Secondary Objective: Combination treatment with finerenone and semaglutide further lowers albuminuria at a population level but will only marginally improve the portion of patients with a 30% reduction in albuminuria when the best drug for each patient is selected., The monitoring of an individual’s drug response and selection of the right drug for each patient can be performed remotely (i.e. at home).;Primary end point(s): Endpoint parameter is the percentage change from baseline in UACR.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Percentage change from baseline in UACR.;Secondary end point(s):Number of missed urine collection in the remote (@home) setting