Actively Recruiting
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
Led by Sarfez Pharmaceuticals, Inc. · Updated on 2026-03-09
30
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with chronic kidney disease
- Estimated glomerular filtration rate (eGFR) between 25 and 60 mL/min/1.72 m2
- Urine albumin-to-creatinine ratio (UACR) between 150 and 3500 mg/g and serum potassium between 4.5 and 5.0 mmol/L
- Clinic seated systolic blood pressure 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 an opposite sex throughout the study
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Uncontrolled hypertension with systolic blood pressure over 170 mmHg
- Primary aldosteronism or 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
- Recent acute kidney injury within 3 months
- Cardiovascular event within 3 months or coronary intervention within 1 month prior to screening
- 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 malignancy
- Current use of potassium supplements or binders
- Known hypersensitivity to sulfonamides, spironolactone, or finerenone
- Pregnant, breastfeeding, or planning pregnancy during study
- Participation in another investigational drug study within 30 days prior to screening
- Considered unsuitable by investigator due to increased risk or interference with study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sarfez Pharmaceuticals, Inc.
Vienna, Virginia, United States, 22182
Actively Recruiting
Research Team
S
Salim Shah, PhD, JD
CONTACT
S
Sophia Shah, MD
CONTACT
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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