New drug HRS-7535 aims to protect kidneys in diabetes patients
NCT ID NCT06415214
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested HRS-7535, a new drug, in 281 adults with type 2 diabetes and diabetic kidney disease. Participants received either the drug or a placebo for 16 weeks. The main goal was to see if HRS-7535 could reduce protein in the urine, a sign of kidney damage, and help preserve kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7535
- What this could lead to
- If it works, HRS-7535 could offer a new way to slow kidney damage in people with type 2 diabetes, potentially reducing the need for dialysis or transplant.
- What could go wrong
- This is an early phase 2 trial with only 281 participants, so results may not apply to everyone. The drug may not improve kidney function or could cause side effects.
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
-
281 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Jul 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 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
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. Male or female subjects, 18-75 years of age at the time of signing informed consent; 2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2; 3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2; 4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators; 5. UACR ≥300 and \<3000 mg/g; 6. HbA1c ≥6.5% and ≤10.0%; 7. ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks; 8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used); 9. Able and willing to provide a written informed consent; Exclusion Criteria: 1. Have type 1 diabetes mellitus or specific type of diabetes; 2. Acute kidney injury or dialysis treatment within 6 months; 3. Kidney transplantation is planned during the trial; 4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 5. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
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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
-
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
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Other studies related to the condition(s) this trial covers.