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New drug cocktail aims to slow kidney disease in IgA patients

NCT ID NCT07030894

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether combining budesonide (Nefecon) and ambrisentan can reduce protein in the urine and preserve kidney function in people with IgA nephropathy who are at risk of kidney failure. About 129 adults will take both pills daily for 36 weeks. Researchers will measure changes in urine protein, kidney filtration rate, and immune markers to see if the combination is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budesonide (Nefecon) and ambrisentan
What this could lead to
If successful, this combination could offer a new way to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong
This is a single-arm, early-phase trial with no placebo group, so results may be less reliable. Side effects from the drugs are possible, and the benefit may not be confirmed in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 129 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 ㎡ Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

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