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Compares treatment options for Hypertension (HTN)
Official title A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT07223502
What this study is testing
What is Combination Product: FDC of spironolactone and ER torsemide?
Combination Product: FDC of spironolactone and ER torsemide is an investigational medicine, given as an once-daily, being studied as a potential treatment for hypertension (htn).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study Comparing the Clinical Benefit of Finerenone Versus a Fixed-Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients with Hypertension and Chronic Kidney Disease.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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);
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.