New drug aims to protect kidneys in IgA nephropathy patients
NCT ID NCT07582133
First seen Jun 24, 2026 · Last updated Jul 23, 2026 · Updated 4 times
Summary
This study tests the long-term safety of HRS-5965 capsules in 380 adults with primary IgA nephropathy, a kidney disease. Participants will take the drug and be monitored for side effects, as well as changes in urine protein and kidney function. The goal is to see if HRS-5965 can safely reduce kidney damage over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-5965 capsules
- What this could lead to
- If successful, this could provide a new treatment option to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
- What could go wrong
- This is an early-phase, open-label trial with no placebo group, so results may not confirm effectiveness. Long-term safety is still unknown, and the drug may cause side effects or fail to outperform existing treatments.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 380 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy; 2. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person. Exclusion Criteria: 1. Hypersensitivity to the study drug or its components; 2. History of immunodeficiency disorders; 3. History of invasive encapsulated bacterial infection; 4. History of malignant neoplasm; 5. The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2;
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new pill slow kidney damage in IgA nephropathy?
- Can a gut metabolite shield the kidneys in IgA nephropathy?
- Can a new pill protect kidneys from IgA nephropathy?
- New pill aims to tame kidney disease in Long-Term trial
- New pill aims to slow kidney disease in IgA nephropathy patients
- New drug aims to reduce kidney damage in IgAN patients