FINEPKT - Finerenone in Proteinuria Patients After Kidney Transplan (FINEPKT)

January 12, 2026 updated by: kewen Chen,MD

An Study on the Efficacy and Safety of Finerenone in Proteinuria Patients After Kidney Transplantation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This project is designed as a single-center, prospective, randomized controlled clinical study with strict inclusion and exclusion criteria. Based on statistical sample size estimation, it aims to enroll kidney transplant recipients with proteinuria, collect basic clinical data of the recipients, and monitor primary and secondary efficacy indicators after transplantation, with the establishment of warning events. The study will further evaluate the long-term clinical benefits of Finerenone in patients with proteinuria after kidney transplantation, in order to formulate better medication plans and provide an ideal reference for similar cases (such as elevated blood creatinine after kidney transplantation).

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200082
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. 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:

    1. 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.
    2. 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.

    4. Serum potassium ≤4.8mmol/L during running-in and screening. 5. Voluntarily sign informed consent

Exclusion Criteria:

  • 1. Kidney transplant recipients have a history of retransplantation, multiple kidney transplants, and transplantation of other organs and tissues.

    2. Known significant non-diabetic nephropathy, including clinically relevant renal artery stenosis.

    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine Albumin-to-Creatinine Ratio
Time Frame: From enrollment to the end of treatment at 6 months"
From enrollment to the end of treatment at 6 months"
creatinine
Time Frame: From enrollment to the end of treatment at 6 months"
From enrollment to the end of treatment at 6 months"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24h UTP
Time Frame: From enrollment to the end of treatment at 6 months"
24-hour Urinary Total Protein
From enrollment to the end of treatment at 6 months"
eGFR
Time Frame: From enrollment to the end of treatment at 6 months"
From enrollment to the end of treatment at 6 months"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

kewen Chen,MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHEC2024-255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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