Nefecon and Ambrisentan in IgA Nephropathy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Hospital of Jilin University

About this trial

Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g/24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with IgA nephropathy by pathological biopsy within 4 years;

Age between 18 and 70 years old;

0.5g/24h ≤ 24-hour urinary protein;

The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula satisfies: eGFR ≥ 30 mL/min/1.73 ㎡

Disqualifiers

Exclude special pathological or clinical kidney disease types such as crescentic glomerulonephritis (pathological diagnosis>50%), minimal change nephropathy with IgA deposition, etc;

Exclude secondary IgA nephropathy, including allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, and mixed connective tissue disease;

Select patients who have experienced any of the following cardiovascular events within the previous 12 weeks: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class II or above heart failure, stroke, etc;

Within 12 weeks prior to the first medication, systemic use (excluding local and nasal inhalation use) of immunosuppressants, including but not limited to glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, Tripterygium wilfordii, etc; Have used an endothelin receptor antagonist within 12 weeks prior to the first medication;

Trial design

Design model

Single group

Treatments tested in this trial

  • "Nefecon®","Ambrisentan"

    Drug

    Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide (Nefecon®), 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally.

Treatment groups

129 Participants
are divided into 1 treatment group
Group A: Combination therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in UPCR (24h urine)

Time frame
From enrollment to the end of treatment at 36 weeks

Secondary outcomes

1

Change in eGFR

Time frame
From enrollment to the end of treatment at 36 weeks
2

Changes in IgA/IgG/IgM and Gd-IgA1 levels at all visits

Time frame
From enrollment to the end of treatment at 36 weeks
3

Annualized eGFR slope at Week 36

Time frame
From enrollment to the end of treatment at 36 weeks

Other outcomes

Sponsors and contacts

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