Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT07030894

Nefecon and Ambrisentan in IgA Nephropathy

Led by The First Hospital of Jilin University · Updated on 2025-09-15

129

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Nefecon and Ambrisentan in IgA Nephropathy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with IgA nephropathy by pathological biopsy within 4 years
  • Age between 18 and 70 years old
  • 24-hour urinary protein of at least 0.5 grams
  • Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher calculated by CKD-EPI formula
Not Eligible

You will not qualify if you...

  • Crescentic glomerulonephritis with more than 50% involvement, minimal change nephropathy with IgA deposits, or other special pathological kidney diseases
  • Secondary IgA nephropathy from allergic purpura, ankylosing spondylitis, lupus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, or mixed connective tissue disease
  • Cardiovascular events within 12 weeks before treatment including myocardial infarction, unstable angina, ventricular arrhythmia, heart failure NYHA class II or above, or stroke
  • Use of systemic immunosuppressants or endothelin receptor antagonists within 12 weeks before treatment
  • Active or untreated latent tuberculosis
  • Active hepatitis or latent hepatitis B with positive HBV DNA or HBsAg positive
  • Immunodeficiency diseases or positive HIV test
  • Malignant tumors diagnosed within past 5 years except treated basal cell carcinoma, resected squamous cell carcinoma, colon polyps, or cervical cancer in situ
  • Kidney transplant recipients
  • Pregnant or breastfeeding women and those planning to conceive during the trial
  • Allergy to human-derived biological products
  • Participation in another clinical trial medication within 4 weeks before treatment
  • Any condition deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

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Research Team

W

Weixia Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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