Nefecon and Ambrisentan in IgA Nephropathy

NCT07030894 | Recruiting Phase 4

• 1 other identifier: 25K183-001
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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

IgA Nephropathy; Chronic Kidney Disease; Proteinuria

Keywords

Proteinuria; IgA Nephropathy; Budesonide; Ambrisentan; Single-arm trial

Outcome Measures

Primary Outcomes (1)

• Percent change in UPCR (24h urine)

  From enrollment to the end of treatment at 36 weeks

Secondary Outcomes (3)

• Change in eGFR

  From enrollment to the end of treatment at 36 weeks

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

  From enrollment to the end of treatment at 36 weeks

• Annualized eGFR slope at Week 36

  From enrollment to the end of treatment at 36 weeks

Study Arms (1)

Combination therapy

EXPERIMENTAL

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.

Drug: "Nefecon®","Ambrisentan"

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.

Combination therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with IgA nephropathy by pathological biopsy within 4 years;
• Age between 18 and 70 years old;
• g/24h ≤ 24-hour urinary protein;
• The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula satisfies: eGFR ≥ 30 mL/min/1.73 ㎡

You may not qualify if:

• 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;
• Active tuberculosis patients and untreated latent tuberculosis patients;
• Patients with active hepatitis or latent hepatitis B (patients with HBcAb positive and HBV DNA positive); According to the results of the five hepatitis B tests, patients with HBsAg positivity should be excluded; Patients who are HBsAg negative but HBcAb positive, regardless of whether HBsAb is positive or negative, need to be tested for HBV-DNA to determine their condition: if HBV-DNA is positive, the patient needs to be excluded; If HBV-DNA is negative, patients can participate in the trial;
• History of immunodeficiency diseases or positive HIV test results (enzyme-linked immunosorbent assay and protein immunoblotting);
• Patients diagnosed with malignant tumors within the past 5 years, except for treated basal cell carcinoma of the skin, effectively resected squamous cell carcinoma of the skin, colon polyps, or cervical cancer in situ;
• Patients undergoing kidney transplantation;
• Pregnant women, lactating women, and men or women with fertility plans during the trial period;
• For individuals allergic to human derived biological products;
• Patients who have received any clinical trial medication within 4 weeks prior to their first use;
• Participants deemed unsuitable by researchers.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA; Renal Insufficiency, Chronic; Proteinuria

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Central Study Contacts

Weixia Sun

CONTACT

+8615804300380; sunwx@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

CN (1)