Health TrialsbyHealthPanel

Effect of Finerenone in IgA Nephropathy

ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Finerenone

    Drug

    10mg or 20mg

  • Placebo

    Drug

    10mg or 20mg

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: FinerenoneExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in uACR between the two groups

Time frame
at 12months

Secondary outcomes

1

eGFR slop

Time frame
at 12months
2

change in uPCR between the two groups

Time frame
at 12months
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: