Nefecon and Ambrisentan in IgA Nephropathy

Sponsor
The First Hospital of Jilin University
Study ID
NCT07030894
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • "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.

Study Details

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

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
129 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy
    Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide , 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally.

Primary Outcome Measure

Percent change in UPCR (24h urine) [ Time Frame: From enrollment to the end of treatment at 36 weeks ]

Central Contacts

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