Finerenone vs Torsemide + Spironolactone for High Blood Pressure

(NEPHRON Trial)

Overseen By Sophia Shah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sarfez Pharmaceuticals, Inc.

Must be taking: Finerenone, Loop diuretics

Must not be taking: Potassium-sparing diuretics, Potassium supplements

Disqualifiers: Type I diabetes, Uncontrolled hypertension, Recent cardiovascular event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

UACR 150-3500 mg/g and serum potassium 4.5 to 5.0 mmol/L

Observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg

Willing and able to comply with all aspects of the protocol and provide written informed consent

Exclusion Criteria

Known hypersensitivity to sulfonamides, spironolactone, or finerenone

Pregnancy, breastfeeding, or planning pregnancy during the study

Participation in another clinical study involving investigational drugs within 30 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a fixed-dose combination of extended-release Torsemide and Spironolactone or continued on stabilized doses of loop diuretic and finerenone

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ER Torsemide
• Finerenone
• Spironolactone

Trial Overview

The study is testing the effectiveness of two treatments: one group will receive finerenone, while another will get a fixed-dose combination of extended-release torsemide and spironolactone. The goal is to compare their benefits in managing hypertension in the context of chronic kidney disease.

How Is the Trial Designed?

Group I: Active Comparator: Fixed-dose combination (FDC) of ER Torsemide and Spironolactone tablet Active Control 1 Intervention

Once daily fixed-dose combination of extended release Torsemide 24 mg and Spironolactone 30 mg

Group II: Active Comparator: Continued on stabilized doses of loop diuretic and finerenone Active Control 1 Intervention

Oral dose of once daily up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone

Who Is Running the Clinical Trial?

Sarfez Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

100+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39291574/

Fixed-dose Combination of Torsemide and ...

The combination of torsemide and spironolactone presents a promising approach to managing conditions such as edema and hypertension.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07015671

Bioavailability and Bioequivalence Study of ER Torsemide ...

The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg Torsemide and 25 mg ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.125.24871?doi=10.1161/HYPERTENSIONAHA.125.24871

Are Diuretics a Clandestine Risk Factor for Patients With ...

Although spironolactone is recommended to control BP in patients with TRH, it is considered a fourth-line drug for use in those whose BP is not ...

4.

japi.org

japi.org/article/japi-72-9-s1-40

Fixed-dose Combination of Torsemide and ...

The combination of torsemide and spironolactone presents a promising approach to managing conditions such as edema and hypertension.

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2024/217686Orig1s000IntegratedR.pdf

217686Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov

aprocitentan's effectiveness in reducing blood pressure when used in combination with other antihypertensive drugs in subjects who are not ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07015671?term=AREA%5BBasicSearch%5D(Spironolactone)&rank=10

Bioavailability and Bioequivalence Study of ER Torsemide ...

The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone ® ( Spironolactone ) alone, and 10 mg Torsemide and 25 mg ...

7.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001356

2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ ...

The focus of this clinical practice guideline is to create a living, working document updating current knowledge in the field of high blood ...