A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).

Eligibility criteria

Qualifiers

Aged ≥18 years , regardless of gender.

Diagnosed with chronic kidney disease (CKD)

Urine albumin-creatinine ratio (UACR) of ≥300 mg/g and ≤5000 mg/g.

Serum potassium≥ lower limit of normal (LLN) and ≤4.8 mmol/L.

Disqualifiers

Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.

Had acute kidney injury or end-stage renal disease, received peritoneal dialysis, hemodialysis or kidney transplantation; or planned to undergo kidney transplantation or chronic renal replacement therapy during the study period.

Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.

History or diagnostic evidence of other secondary hypertension.

Trial design

Treatments tested in this trial

  • SAL0140 Tablets
  • SAL0140 Tablets
  • SAL0140 placebo

Treatment groups

249 Participants
are divided into 3 treatment groups