Finerenone vs Fixed Dose Combo for Hypertension and CKD
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Sponsor
Sarfez Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure and chronic kidney disease to compare two treatments. Participants will take the assigned medication for about 30 days while being monitored.
Are You a Good Fit for This Trial?
Must be takingFurosemide
Rules you outAcute kidney injuryType 1 diabetesPrimary aldosteronism
You may be able to join if
I am at least 18 years old.
I have chronic kidney disease.
I have an eGFR between 25 and 60.
I have a UACR between 150 and 3500 mg/g.
My systolic blood pressure is between 130 and 170 mmHg.
I am currently taking furosemide or an equivalent diuretic.
I can provide written consent to participate.
I will use effective contraception during the study.
You may not be able to join if
I have type 1 diabetes.
My blood pressure is higher than 170 mmHg.
I have primary aldosteronism or similar disorders.
My serum potassium levels are not between 4.5 and 5.0 mmol/L.
I have had acute kidney injury in the last 3 months.
I had a heart event in the last 3 months.
I was hospitalized for worsening heart failure in the last 30 days.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult male and female patients aged ≥18 years;
2. Are diagnosed with a CKD;
3. Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2;
4. Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L;
5. Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg;
6. Are rec…
Inclusion Criteria:
1. Adult male and female patients aged ≥18 years;
2. Are diagnosed with a CKD;
3. Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2;
4. Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L;
5. Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg;
6. 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;
7. 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);
8. Willing to use effective methods of contraception during sexual intercourse with an opposite sex throughout the study.
Exclusion Criteria:
1. Have a diagnosis of type I diabetes mellitus (T1DM);
2. Have uncontrolled hypertension (SBP \>170 mmHg);
3. Have primary aldosteronism or endocrine disorders;
4. Have serum potassium \>5.0 or \<4.5 mmol/L at screening;
5. Unable to continue on 10 mg finerenone or require daily dose of more than 80mg furosemide or equivalent doses of other loop diuretics
6. Have a recent diagnosis of acute kidney injury (≤3 months);
7. 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 coronary intervention within 1 month prior to screening;
8. Had hospitalized for worsening heart failure in last 30 days;
9. Have an autosomal dominant or recessive polycystic kidney disease;
10. Have an Addison's disease;
11. Have Hepatic insufficiency classified as Child-Pugh;
12. Have a diagnosis of Lupus nephritis or anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis or any other kidney diseases requiring immunosuppressive therapy;
13. Have a history of organ transplant;
14. Require treatment with potassium-sparing diuretics;
15. Have an active malignancy;
16. Currently taking potassium supplement or potassium binders;
17. Have known hypersensitivity to sulfonamides or related compounds or spironolactone or finerenone;
18. Is pregnant, breastfeeding, or planning to become pregnant during the study;
19. Have participated in another clinical study involving any investigational drug within 30 days prior to Screening;
20. 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 reviewing medical and psychiatric history, physical examination, and laboratory evaluation.
Contacts
No contact information available.
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