IgA Nephropathy (IgAN)
Conditions
Brief summary
: IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.
Interventions
DRUGFinerenone
Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist. Planned dose - 10 mg/day
Sponsors
Botkin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\> 18 years) with the primary IgAN diagnosed by kidney biopsy; * Treatment with stable doses of iRAS or/and iSGLT2 inhibitors for at least 3 months prior inclusion into the trial; * Blood pressure \< 140/90 mm Hg * 24-hour urinary albumin excretion \> 300 mg
Exclusion criteria
* Kidney transplantation in medical history * Chronic hepatic disease, including hepatitis, malignant tumor, active malignancy; * Heart failure with ejection fraction \<40%; * Acute myocardial infarction and/or stroke less then 3 months before including in trial; * Presence ANCA in serum * Ongoing immunosuppressive treatment * eGFR \< 20 ml/min * Pregnancy and breastfeeding * Uncontrolled blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median change in albuminuria from baseline | 6 months | 24-hour urinary albumin excretion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median change in eGFR from baseline | 6 months | calculated based on creatinine level |
Countries
Russia
Contacts
Primary ContactEvgeny Shytov, PhD
Backup ContactAnastasiia Zykova, PhD
Outcome results
None listed