Kidney function may affect how HRS-1893 works in heart disease
NCT ID NCT06775834
First seen Jun 26, 2026 ยท Last updated Jun 26, 2026
Summary
This completed Phase 1 study looked at how HRS-1893 tablets are processed in people with mild or moderate kidney impairment compared to healthy subjects. The goal was to understand dosing needs for patients with hypertrophic cardiomyopathy who also have kidney issues. Twenty-four adults took part, and researchers measured drug levels in the blood and urine, along with safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-1893 tablets
- What this could lead to
- If successful, this study could help doctors determine the right dose of HRS-1893 for people with kidney problems who have hypertrophic cardiomyopathy.
- What could go wrong
- This is a very early, small study (24 people) focused on drug levels and safety, not on treating the disease. It may not lead to any treatment benefit.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Feb 2025
- Finished
-
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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial; 2. Male or female subjects aged 18 to 65 (including 18 and 65); 3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28); 4. The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min. Exclusion Criteria: 1. Suspected allergy to the study drug or any component of the study drug; 2. Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris; 3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy); 4. Patients with a history of gastric or intestinal surgery that may affect drug absorption; 5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study; 6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator; 7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period; 8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.
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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
-
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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