Finerenone vs Torsemide + Spironolactone for High Blood Pressure
(NEPHRON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of two treatments for managing high blood pressure in individuals with chronic kidney disease. One group will take a combination pill of extended-release Torsemide and Spironolactone, while the other group will continue with their usual doses of loop diuretics (which help remove excess fluid) and Finerenone (which reduces blood pressure and protects the kidneys). The trial aims to determine which treatment better improves symptoms and manages these conditions. Individuals with chronic kidney disease and stable high blood pressure may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you must be able to continue taking a 10 mg daily dose of finerenone and up to 80 mg of furosemide or equivalent loop diuretics. If you are taking potassium supplements or potassium-sparing diuretics, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining extended-release Torsemide and Spironolactone effectively manages high blood pressure. This combination is usually well-tolerated, and studies suggest it works well for conditions like swelling (edema) and high blood pressure.
For Finerenone, studies have found it improves heart and kidney health in people with chronic kidney disease. However, some individuals might experience low blood pressure as a side effect. Overall, Finerenone has been well-tolerated in large groups.
Both treatment options appear to have manageable safety profiles according to current research. Discuss any concerns with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for high blood pressure because they offer unique approaches compared to current options. The fixed-dose combination of extended-release Torsemide and Spironolactone is noteworthy because it combines two powerful diuretics in one pill, potentially simplifying treatment plans and enhancing adherence. On the other hand, Finerenone offers a novel mechanism as a non-steroidal mineralocorticoid receptor antagonist, which may provide a safer option with fewer side effects than traditional treatments. These innovations could lead to more effective and patient-friendly management of high blood pressure.
What evidence suggests that this trial's treatments could be effective for high blood pressure?
This trial will compare two treatment approaches for managing high blood pressure. One arm involves a fixed-dose combination of extended-release torsemide and spironolactone. Research has shown this combination effectively controls high blood pressure in patients unresponsive to typical treatments. The other arm involves continued use of stabilized doses of a loop diuretic and finerenone. Studies have found that finerenone significantly aids patients with chronic kidney disease and slightly lowers blood pressure, improving heart and kidney health. Both treatments hold potential for managing high blood pressure, particularly in complex cases involving chronic kidney disease.13467
Who Is on the Research Team?
Chris Wilcox, MD, PhD
Principal Investigator
Sarfez Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with high blood pressure and chronic kidney disease. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a specific range of blood pressure or kidney function levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a fixed-dose combination of extended-release Torsemide and Spironolactone or continued on stabilized doses of loop diuretic and finerenone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ER Torsemide
- Finerenone
- Spironolactone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarfez Pharmaceuticals, Inc.
Lead Sponsor