A Study Comparing the Clinical Benefit of Finerenone Vers... | NCT07223502

NCT07223502

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Comparator: Fixed-dose combination (FDC) of ER Torsemide and Spironolactone tablet	Active Comparator	Once daily fixed-dose combination of extended release Torsemide 24 mg and Spironolactone 30 mg	Drug: Combination Product: FDC of spironolactone and ER torsemide
Active Comparator: Continued on stabilized doses of loop diuretic and finerenone	Active Comparator	Oral dose of once daily up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone	Drug: Combination Product: Stabilized doses of loop diuretic and finerenone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combination Product: FDC of spironolactone and ER torsemide	Drug	The usual starting torsemide daily dose ranges from 5-10 mg (for hypertension) to 10-20 mg (for heart failure). The initial dose for treatment of heart failure or hypertension is 25 mg daily.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction	SBP ≥10 mmHg reduction from baseline (binary: yes/no).	12 weeks
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction	NCB is defined as UACR ≥30% reduction from baseline (binary: yes/no).	12 weeks
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction	Serum K⁺ ≤5.0 mmol/L at end of treatment (binary: y/no)	12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male and female patients aged ≥18 years;
Are diagnosed with a CKD;
Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2;
Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L;
Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg;
Are receiving up to an 80 mg daily dose of furosemide or an equivalent dose of other loop diuretics and and 10 mg daily dose of finerenone for 30 days;
Willing and able to comply with all aspects of the protocol and to provide written informed consent from the patient or patient's legally acceptable representative (LAR);
Willing to use effective methods of contraception during sexual intercourse with an opposite sex throughout the study.

Exclusion Criteria:

Have a diagnosis of type I diabetes mellitus (T1DM);
Have uncontrolled hypertension (SBP >170 mmHg);
Have primary aldosteronism or endocrine disorders;
Have serum potassium >5.0 or <4.5 mmol/L at screening;
Unable to continue on 10 mg finerenone or require daily dose of more than 80mg furosemide or equivalent doses of other loop diuretics
Have a recent diagnosis of acute kidney injury (≤3 months);
Had a cardiovascular event within 3 months prior to screening (e.g., myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting) or elective percutaneous coronary intervention within 1 month prior to screening;
Had hospitalized for worsening heart failure in last 30 days;
Have an autosomal dominant or recessive polycystic kidney disease;
Have an Addison's disease;
Have Hepatic insufficiency classified as Child-Pugh;
Have a diagnosis of Lupus nephritis or anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis or any other kidney diseases requiring immunosuppressive therapy;
Have a history of organ transplant;
Require treatment with potassium-sparing diuretics;
Have an active malignancy;
Currently taking potassium supplement or potassium binders;
Have known hypersensitivity to sulfonamides or related compounds or spironolactone or finerenone;
Is pregnant, breastfeeding, or planning to become pregnant during the study;
Have participated in another clinical study involving any investigational drug within 30 days prior to Screening;
Is considered to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation.

Name	Role	Phone	Extension	Email
Salim Shah, PhD, JD	Contact	877-872-7339		info@sarfez.com
Sophia Shah, MD	Contact	877-872-7339		Sophia.Shah@sarfez.com

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases