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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SAL0140 Tablets

    Drug

    SAL0140 Tablets

  • SAL0140 Tablets

    Drug

    SAL0140 Tablets

  • SAL0140 placebo

    Drug

    placebo

Treatment groups

249 Participants
are divided into 3 treatment groups
Group A: Low-dose groupExperimental treatment 1 intervention
Group B: High-dose groupExperimental treatment 1 intervention
Group C: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The baseline change of UACR

Change from baseline in UACR compared to placebo at Week 16

Time frame
at week 16

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: