Effect of Finerenone in IgA Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finerenone, Placebo.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy
Overview
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.
Detailed description
This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study.
The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio:
* Finerenone 10mg/20 mg * Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.
Interventions
- Drug Finerenone
10mg or 20mg - Drug Placebo
10mg or 20mg
Primary outcome measures
- change in uACR between the two groups [Time frame: at 12months]
Secondary outcome measures (4)
- eGFR slop [Time frame: at 12months]
- change in uPCR between the two groups [Time frame: 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); [Time frame: 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. [Time frame: at 12months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06580288 · IIT20240069C-R1