NCT06460987

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

May 28, 2024

Last Update Submit

June 10, 2024

Conditions

FinerenoneIgA NephropathyProteinuriaSafety Issues

Keywords

finerenoneIgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • percentage change in PCR from baseline to 6 months

    Collect PCR data before enrolment and at month 6 and calculate the percentage change

    6 month

Secondary Outcomes (6)

  • percentage change in PCR from baseline to 1, 2 and 3 months

    1, 2 and 3 month

  • frequency of patients with a 30% and 50% decrease in PCR

    6 month

  • the level of change in eGFR

    6 month

  • the level of change in blood sodium

    6 month

  • the level of change in serum creatinine

    6 month

  • +1 more secondary outcomes

Study Arms (4)

A group: FINE+RASI group;

Patients treated with RASI and finerenone

Drug: FinerenoneDrug: RAS inhibitor

B group: RASI group;

Patients treated with RASI only

Drug: RAS inhibitor

C group: immune suppressive + FINE + RASI;

Patients receiving immunosuppressive drugs and RASIs

Drug: FinerenoneDrug: RAS inhibitorDrug: Immune Suppressant

D group: immune suppressive + RASI;

Patients receiving immunosuppressants, RASI and finerenone

Drug: RAS inhibitorDrug: Immune Suppressant

Interventions

FinerenoneDRUG

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

Also known as: FINE
A group: FINE+RASI group;C group: immune suppressive + FINE + RASI;
RAS inhibitorDRUG

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Also known as: RASI
A group: FINE+RASI group;B group: RASI group;C group: immune suppressive + FINE + RASI;D group: immune suppressive + RASI;
Immune SuppressantDRUG

Receive immune suppressant treatment as specified in the KDIGO guidelines

Also known as: immunosupressive
C group: immune suppressive + FINE + RASI;D group: immune suppressive + RASI;

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with IGA nephropathy by renal biopsy who met the inclusion exclusion criteria, were able to be followed up regularly, and had clinical follow-up data.

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Yiwu, Zhejiang, China

Location

Related Publications (1)

  • Wang QR, Wu L, Huang J, Pan H, Wang XF, Li L, Han F, Wang YF, Wu ML, Yang Y. Efficacy and safety of finerenone in IgA nephropathy: an observational multicentre study. Clin Kidney J. 2025 Apr 28;18(5):sfaf125. doi: 10.1093/ckj/sfaf125. eCollection 2025 May.

    PMID: 40357496DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuria

Interventions

finerenoneImmunosuppressive Agents

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Qiaorui Wang, bachelor

    Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 14, 2024

Study Start

December 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)