Actively Recruiting
A Randomized, Parallel, Two-Arm Study Comparing the Net Clinical Benefit of Finerenone Versus a Fixed-Dose Combination of Extended-Release Torsemide and Spironolactone in Patients with Hypertension and Proteinuric Chronic Kidney Disease
Led by Sarfez Pharmaceuticals, Inc. · Updated on 2026-03-09
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is investigating the net clinical benefit of finerenone compared to a fixed-dose combination of extended-release torsemide and spironolactone in adult patients with hypertension and proteinuric chronic kidney disease. It is a randomized, parallel, two-arm study designed to evaluate these treatments specifically in patients who have certain kidney function and blood pressure measures. The study is sponsored by Sarfez Pharmaceuticals, Inc. and focuses on improving clinical outcomes in this population. Participants will be randomly assigned to one of two groups: one group will receive a once-daily fixed-dose combination tablet containing 24 mg of extended-release torsemide and 30 mg of spironolactone, while the other group will continue stabilized doses of loop diuretics (up to 80 mg furosemide or equivalent) combined with 10 mg daily of finerenone. The treatment phase will last at least 12 weeks, during which blood pressure, urinary albumin-to-creatinine ratio, and serum potassium levels will be closely monitored to compare the treatments' clinical benefits. Throughout the study, participants will undergo regular assessments including blood pressure measurements, laboratory tests for kidney function and potassium levels, and monitoring for any adverse events. The primary outcomes focus on reductions in systolic blood pressure, urinary albumin-to-creatinine ratio, and serum potassium after 12 weeks of treatment. Participants will be followed until the study's completion in 2026, with safety and adherence carefully tracked to ensure accurate evaluation of the treatment effects.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 years or older
- Diagnosed with chronic kidney disease (CKD)
- Estimated glomerular filtration rate (eGFR) between 25 and 60 mL/min/1.72 m2
- Urinary albumin-to-creatinine ratio (UACR) between 150 and 3500 mg/g
- Serum potassium level between 4.5 and 5.0 mmol/L
- Clinic seated systolic blood pressure (SBP) between 130 and 170 mmHg
- Receiving up to 80 mg daily furosemide or equivalent loop diuretics and 10 mg daily finerenone for at least 30 days
- Willing and able to comply with the protocol and provide written informed consent
- Willing to use effective contraception during sexual intercourse with opposite sex throughout the study
You will not qualify if you...
- Diagnosis of type I diabetes mellitus (T1DM)
- Uncontrolled hypertension with systolic blood pressure over 170 mmHg
- Primary aldosteronism or other endocrine disorders
- Serum potassium outside 4.5 to 5.0 mmol/L at screening
- Unable to continue 10 mg finerenone or requiring more than 80 mg daily furosemide or equivalent loop diuretics
- Acute kidney injury diagnosed within past 3 months
- Cardiovascular event within 3 months prior (e.g., heart attack, stroke, pulmonary embolism)
- Hospitalization for worsening heart failure in last 30 days
- Autosomal dominant or recessive polycystic kidney disease
- Addison's disease
- Hepatic insufficiency classified as Child-Pugh
- Lupus nephritis, ANCA-associated vasculitis, or other kidney diseases needing immunosuppressive therapy
- History of organ transplant
- Need for potassium-sparing diuretics
- Active cancer
- Taking potassium supplements or binders
- Known allergy to sulfonamides, spironolactone, or finerenone
- Pregnant, breastfeeding, or planning pregnancy during study
- Participation in another investigational drug study within 30 days prior to screening
- Any other condition increasing risk or interfering with study outcomes as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are randomly assigned to receive either a fixed-dose combination of extended-release Torsemide and Spironolactone or stabilized doses of loop diuretics and finerenone to manage hypertension and chronic kidney disease.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Sarfez Pharmaceuticals, Inc.
Vienna, Virginia, United States, 22182
Actively Recruiting
Research Team
S
Salim Shah, PhD, JD
S
Sophia Shah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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