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Active Not RecruitingNCT07356388

FINEPKT - Finerenone in Proteinuria Patients After Kidney Transplan

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

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
54 (estimated)
Sponsor
kewen Chen,MD · Academic / Other
Sex
All
Age
19 Years – 65 Years
Healthy volunteers
Not accepted

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.

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).

Conditions

Interventions

TypeNameDescription
DRUGExperimental GroupOral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + finelidone (10 or 20mg orally once a day)
DRUGControl (Standard treatment)Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + Dapagliflozin (10 or 20mg orally once a day)

Timeline

Start date
2025-01-30
Primary completion
2027-10-01
Completion
2028-03-31
First posted
2026-01-21
Last updated
2026-01-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07356388. Inclusion in this directory is not an endorsement.