HRS-1780 Demonstrates Positive Safety, Efficacy Treating Patients With CKD

Findings presented at the American Society of Nephrology (ASN) 2025 Kidney Week demonstrated the positive efficacy and safety profile of HRS-1780 (Shandong Suncadia Medicine Co, Ltd) when treating patients with chronic kidney disease (CKD).¹

HRS-1780 is a nonsteroidal mineralocorticoid receptor antagonist (MRA) that blocks harmful effects in the heart and kidneys and is critical in the treatment of CKD and heart failure. In CKD, they help keep glomeruli—small filters in your kidneys—healthy and lower a patient’s urine albumin-creatinine ratio (uACR) levels. They can also lower the risk of cardiovascular disease, including heart failure, heart attack, or stroke, in patients. Currently, the only nonsteroidal MRA to be approved by the FDA for the treatment of CKD is finerenone (Kerendia; Bayer), meaning that it is crucial that patients have additional treatment options.²

Previous research published in Drug Design, Development and Therapy demonstrated HRS-1780’s pharmacokinetics and safety profiles, which did not differ significantly between patients with renal impairments and their healthy counterparts. Specifically, among the 27 participants who completed the study, HRS-1780 was rapidly absorbed and eliminated, with a T_max of about 0.50 to 0.52 hours and a t_1/2 of 2.06 to 2.56 hours. Exposure to HRS-1780 was also comparable between patients with mild renal impairment and moderate renal impairment. Similar plasma protein binding among different renal function groups was also observed, suggesting a consistent effect of renal function on total and unbound HRS-1780. Renal clearance of HRS-1780 decreased with the severity of renal impairment, but renal elimination of HRS-1780 was minimal. Notably, renal impairment was not observed to be associated with an increased risk of adverse events.³

The findings presented at ASN 2025 Kidney Week are from a multicenter, randomized, double-blind, placebo-controlled, parallel-design phase 2 clinical trial (NCT06221059)⁴, in which the efficacy and safety of HRS-1780 were assessed in the treatment of patients with CKD. In this study, patients were randomly assigned to receive either 10 mg or 20 mg of HRS-1780 or a placebo. The primary end point was the percentage change from baseline to week 13 in uACR. All enrolled patients had an estimated glomerular filtration rate from 30 to 90 mL/min/1.73 m², UACR from 300 to 3000 mg/g, a hemoglobin A_1c less than 9.0%, and blood potassium of 4.8 mmol/L or lower and had maintained treatment with the maximum tolerated dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers for at least 4 weeks to be randomly assigned.^1,4

In total, 134 patients with CKD were randomly assigned to treatment and received at least 1 dose of the study drug. The baseline demographics and clinical characteristics were balanced across all the treatment groups. At week 13, the placebo-corrected percentage change from baseline in uACR was approximately –29.9% (P = .0112) and –53.5% (P < .0001) in the 10- and 20-mg HRS-1780 groups, respectively. The placebo-corrected percentage change from baseline in 24-hour urine protein quantification was –29.4% (P = .0068) and –47.3% (P < .0001) in these respective groups. Regarding safety, the incidence of treatment-emergent adverse events (AEs) was approximately 65.9%, 64.4%, and 55.6% with the HRS-1780 10-mg, 20-mg, and placebo groups, respectively. Of note, the incidence of hyperkalemia was 4.5% and 15.6% with the 10- and 20-mg HRS-1780 dosages.¹

As novel nonsteroidal MRAs such as HRS-1780 emerge as potential therapies for CKD, pharmacists play a key role in translating these advances into safe and effective patient care. Pharmacists can evaluate patient eligibility based on renal function, albuminuria, potassium levels, and concurrent use of renin–angiotensin system inhibitors, ensuring appropriate selection and dosing as new agents enter real-world practice. Additionally, considering the known risk of hyperkalemia with MRAs, pharmacists can help monitor laboratory parameters, identify drug–drug interactions, and educate patients on signs of adverse events. Supporting adherence, counseling patients on the cardiovascular and renal benefits of therapy, and collaborating with nephrology and cardiology teams to optimize outcomes is crucial, especially for patients with comorbid CKD and type 2 diabetes.

As the therapeutic landscape for CKD expands beyond finerenone, pharmacist involvement will be essential to safely integrating new options—like HRS-1780—into evidence-based, patient-centered care.

REFERENCES

1. Liu Z, Zhang H, Li X, et al. Multicenter, randomized, double-blind, placebo-controlled phase 2 study evaluating the efficacy and safety of HRS-1780 tablets in patients with CKD: TH-PO1189. J Am Soc Nephrol. 2025;36(10S):10.1681/ASN.2025nfs8tpnw. doi:10.1681/ASN.2025nfs8tpnw

2. Non-steroidal MRAs. National Kidney Foundation. Updated May 15, 2023. Accessed December 23, 2025. https://www.kidney.org/kidney-topics/non-steroidal-mras

3. Fei Y, Xie Z, Luo Y, et al. Pharmacokinetics and safety of HRS-1780 in renal impaired subjects: a multicenter, non-randomized, open-label study. Drug Des Devel Ther. 2025;19:3751-3761. doi:10.2147/DDDT.S500384

4. Efficacy and safety of HRS-1780 tablets and henagliflozin proline tablets in patients with chronic kidney disease. ClinicalTrials.gov. Updated December 1, 2025. Accessed December 23, 2025. https://www.clinicaltrials.gov/study/NCT06221059