Can a new pill protect kidneys from IgA nephropathy?
NCT ID NCT06137768
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests an experimental drug called HRS-5965 in people with primary IgA nephropathy, a kidney disease that can lead to kidney failure. The goal is to see if the drug can reduce protein leakage in the urine, a sign of kidney damage. About 123 adults with confirmed IgA nephropathy will receive either HRS-5965 or a placebo to compare effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called HRS-5965
- What this could lead to
- If successful, HRS-5965 could offer a new treatment option to slow kidney damage in people with IgA nephropathy.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Side effects are still being studied.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
123 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Oct 2025
- Lead sponsor
-
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
-
18 years and older
- 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 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. Able and willing to provide a written informed consent; 2. Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2; 3. Primary IgA nephropathy was confirmed by renal biopsy within 5 years; 4. 24-UPE≥ 0.75g /24h, or UPCR≥ 0.8g/g at screening and prior to randomization; 5. eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula) 6. A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily takes effective contraceptive measures (including the partner); 7. Receiving optimal supportive therapy including RAS blockers for 12 weeks and stabilizing the dose for at least 4 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization; Exclusion Criteria: 1. Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator; 2. Patients with secondary IgA nephropathy as determined by the investigator; 3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%; 4. Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; 5. Have any organ transplant; 6. Patients with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or subjects with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization; 7. Patients with a history of malignant neoplasms; 8. Patients with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period; 9. Patients with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening; 10. The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion; 11. As determined by the investigator, the subject has any of the following: progression or recovery of a disease; 12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening; 13. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or who were within the follow-up period of a clinical study, or within 5 half-lives of the investigational drug, or within 30 days (whichever is older) before screening; 14. Women who are pregnant or breastfeeding; 15. A history of drug abuse; 16. Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary IgA nephropathy are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Beijing University First Hospital
Beijing, Beijing Municipality, 100034, 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?
- 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 protect kidneys in IgA nephropathy patients
- New drug aims to reduce kidney damage in IgAN patients