New pill shows promise for kidney disease in Mid-Stage trial
NCT ID NCT05016323
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called HR19042 in 316 adults with IgA nephropathy, a kidney disease. The goal was to see if the drug can reduce protein in the urine, a sign of kidney damage, and find the best dose. Participants took either the drug or a placebo for a set period, and researchers measured changes in kidney function and protein levels.
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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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316 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
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Aug 2025
- 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
-
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female or male patients ≥18 years old; 2. Biopsy-confirmed primary IgA nephropathy; 3. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g; 4. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2; 5. Willing and able to take adequate contraception during the trial; 6. Willing and able to give informed consent and follow the protocols during the trial. Exclusion Criteria: 1. Systemic diseases which could lead to secondary IgA nephropathy; 2. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days; 3. Patients with severe cardiovascular diseases; 4. Patients diagnosed with malignancy within the past 5 years; 5. Patients with liver cirrhosis; 6. Patients received organ transplantation; 7. Patients with uncontrolled Type 1 or 2 diabetes; 8. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests; 9. Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening; 10. Patients treated with any systemic corticosteroids within the past 3 months before screening.
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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.
Contacts and locations
Locations
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NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 10,000 kidneys under the microscope: registry maps IgA Nephropathy's course
- Microbes in the mouth and gut may hold clues to a common kidney disease
- Can a transplant drug tame stubborn kidney disease?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?
- Can a new injection slow kidney disease in children?