FINEPKT - Finerenone in Proteinuria Patients After Kidney Transplan

NCT07356388 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CHEC2024-255
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Finerenone works to treat proteinuria patients after kidney transplantation. It will also learn about the safety of Finerenone. The main questions it aims to answer are: Does Finerenone lower the number of UACR values in kidney transplant recipients?? What medical problems do participants have when taking Finerenone? Researchers will compare Finerenone to Dapagliflozin to see if Finerenone works to treat proteinuria patients after kidney transplantation.

Conditions

Kidney Transplantation Recipients; Proteinuria Patients

Keywords

proteinuria patients; kidney transplantation; Finerenone

Outcome Measures

Primary Outcomes (2)

• Urine Albumin-to-Creatinine Ratio

  From enrollment to the end of treatment at 6 months"

• creatinine

  From enrollment to the end of treatment at 6 months"

Secondary Outcomes (2)

• 24h UTP

  From enrollment to the end of treatment at 6 months"

• eGFR

  From enrollment to the end of treatment at 6 months"

Interventions

Experimental Group DRUG

Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + finelidone (10 or 20mg orally once a day)

Control (Standard treatment) DRUG

Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + Dapagliflozin (10 or 20mg orally once a day)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult kidney transplant patients (≥18 years old) 2. The diagnosis and screening of chronic kidney disease (CKD) after kidney transplantation meet at least one of the following criteria:
• Persistent high proteinuria (UACR of 30-300 mg/g, more than 2 of 3 early morning urination samples) and estimated glomerular filtration rate (eGFR) of 25-60ml/min/1.73m2 (CKD EPI) and the presence of diabetic retinopathy.
• Persistent extremely high albuminuria (UACR≥300mg/g, more than 2 of 3 early morning urination samples) and eGFR≤25 mL /min/1.73m2 (CKD EPI) 3. Previous treatments with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor block (ARB) are as follows: A. At least 4 weeks prior to the run-in visit, subjects should receive ACEI or ARB or a combination of both
• b. At the beginning of the run-in visit, subjects were receiving only ACEI or ARB or a combination of both.
• c. At least 4 weeks prior to the screening visit, subjects should be treated with only the maximum tolerated labeled dose (but not less than the minimum labeled dose) of ACEI or ARB, preferably without adjustment of dose or drug selectivity or any other antihypertensive or antiglycemic therapy.
• \. Serum potassium ≤4.8mmol/L during running-in and screening. 5. Voluntarily sign informed consent

You may not qualify if:

• \. Kidney transplant recipients have a history of retransplantation, multiple kidney transplants, and transplantation of other organs and tissues.
• \. Known significant non-diabetic nephropathy, including clinically relevant renal artery stenosis.
• \. Uncontrolled arterial hypertension (i.e. mean sitting systolic blood pressure (SBP) ≥170mmHg at presentation, sitting diastolic blood pressure (DBP) ≥110mmHg, or mean sitting SBP≥160mmHg, sitting DBP≥ 100mmHg at screening) 4. In patients with type I diabetes, the hemoglobin a1C (HbA1c) is \>12%. 5. Uncontrolled hypotension; The mean SBP at run-in visit or screening visit was \<90mmHg 6. Chronic heart failure clinically diagnosed at run-in visit with decreased ejection fraction (HFrEF) and persistent symptoms (New York Heart Association \[NYHA\] Grade II-IV) (Level 1A recommendation for salocorticoid receptor antagonist MRA) 7. Hospitalization for stroke, transient ischemic attack, acute coronary syndrome, or worsening heart failure within 30 days prior to screening 8. Hemokalium was higher than 5.5mmol/L within 12 weeks after treatment due to acute renal failure 9. Patients with malignant tumors or other metabolic disorders have a history of allergic diseases or allergies 10. Severe liver damage 11 Pregnant or lactating women 12. Severe infectious diseases 13. There are other circumstances that the investigator deems inappropriate to participate in the clinical trial.

Sponsors & Collaborators

• kewen Chen,MD: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Related Publications (8)

• Barrera-Chimal J, Lima-Posada I, Bakris GL, Jaisser F. Mineralocorticoid receptor antagonists in diabetic kidney disease - mechanistic and therapeutic effects. Nat Rev Nephrol. 2022 Jan;18(1):56-70. doi: 10.1038/s41581-021-00490-8. Epub 2021 Oct 21.

  PMID: 34675379 BACKGROUND

• Al Dhaybi O, Bakris GL. Non-steroidal mineralocorticoid antagonists: Prospects for renoprotection in diabetic kidney disease. Diabetes Obes Metab. 2020 Apr;22 Suppl 1:69-76. doi: 10.1111/dom.13983.

  PMID: 32267074 BACKGROUND

• Kolkhof P, Joseph A, Kintscher U. Nonsteroidal mineralocorticoid receptor antagonism for cardiovascular and renal disorders - New perspectives for combination therapy. Pharmacol Res. 2021 Oct;172:105859. doi: 10.1016/j.phrs.2021.105859. Epub 2021 Aug 28.

  PMID: 34461222 BACKGROUND

• Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.

  PMID: 34015478 BACKGROUND

• Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

  PMID: 26325557 BACKGROUND

• Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.

  PMID: 33198491 BACKGROUND

• Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.

  PMID: 34449181 BACKGROUND

• Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

  PMID: 33264825 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 21, 2026
• Study Start: January 30, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)