Clinical trial

Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA

Name

KY-2024-081

Description

IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.

Trial arms

Trial start

2022-12-01

Estimated PCD

2024-03-31

Trial end

2024-03-31

Status

Completed

Treatment

Finerenone

Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels

Arms:

A group: FINE+RASI group;, C group: immune suppressive + FINE + RASI;

Other names:

FINE

RAS inhibitor

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Arms:

A group: FINE+RASI group;, B group: RASI group;, C group: immune suppressive + FINE + RASI;, D group: immune suppressive + RASI;

Other names:

RASI

Immune Suppressant

Receive immune suppressant treatment as specified in the KDIGO guidelines

Arms:

C group: immune suppressive + FINE + RASI;, D group: immune suppressive + RASI;

Other names:

immunosupressive

Size

245

Primary endpoint

percentage change in PCR from baseline to 6 months

6 month

Eligibility criteria

Inclusion Criteria: * primary IgAN diagnosed by renal biopsy; * receive RASI inhibitors for at least 3 months; * serum potassium \<5 mmol/L; * protein-to-creatinine ratio (PCR) \>0.3 mg/g Exclusion Criteria: * secondary IgAN; * autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, lupus nephritis,; * previous renal transplantation; * chronic hepatic disease, malignant tumor, active malignancy, heart failure with ejection fraction \<40%; * followed up less than 6 months;

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 245, 'type': 'ACTUAL'}}

Updated at

2024-06-14

1 organization

3 products

4 indications

Organization

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Product

Finerenone

Indication

Finerenone

Indication