Effect of Finerenone in IgA Nephropathy

NCT06580288 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT20240069C-R1
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy. The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• change in uACR between the two groups

  at 12months

Secondary Outcomes (4)

• eGFR slop

  at 12months

• change in uPCR between the two groups

  at 12months

• renal failure (eGFR decline of 40% or progression to ESKD, defined as initiation of dialysis, kidney transplantation, or eGFR ≤ 15 ml/min/1.73 m²);

  at 12months

• cardiovascular event endpoints: cardiovascular death or non-fatal myocardial infarction or non-fatal stroke; hospitalization due to heart failure; major cardiovascular events; all-cause mortality.

  at 12months

Study Arms (2)

Finerenone

EXPERIMENTAL

Drug: Finerenone

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Finerenone DRUG

10mg or 20mg

Finerenone

Placebo DRUG

10mg or 20mg

placebo

Eligibility Criteria

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

You may qualify if:

• Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;
• Age ≥ 18 years;
• Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showing urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerated dose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;
• eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;
• Serum potassium level ≤ 4.8 mmol/L;
• SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;
• LVEF \> 40%;
• Willing and able to provide informed consent.

You may not qualify if:

• There are clear indications for the use of immunosuppressive therapy, such as: nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30 g/L), pathological minimal change disease combined with IgA nephropathy; the proportion of crescents in kidney biopsy is ≥ 50%.
• Any existing life-threatening condition with a life expectancy of less than 2 years;
• Active infection, HBV infection, or active lesions (nodules, cavities, or tuberculomas);
• AKI causing renal dysfunction;
• Use of steroids/immunosuppressive drugs within the past 3 months;
• History of malignant tumors, regardless of treatment status or evidence of local recurrence or metastasis;
• Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the investigational drug;
• History of drug or alcohol abuse within the past 12 months;
• History of drug allergies or contraindications;
• Previous noncompliance or unwillingness to follow the study protocol;
• Any condition that may affect safety or efficacy;
• History of kidney transplantation or currently receiving immunosuppressive treatment;
• Pregnant or breastfeeding women;
• Obese patients with a BMI \> 35.

Sponsors & Collaborators

• Zhejiang University: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

finerenone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Guizhen Yu

CONTACT

15268801632; gzysmile@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share