drugset / Trial / NCT05593575

Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease

NCT05593575

Phase 2 Completed 305 enrolled Shanghai Pharmaceuticals Holding Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

To preliminarily evaluate the efficacy and safety of the renin inhibitor (SPH3127 tablets) in reduction in proteinuria in patients with diabetic kidney disease with valsartan as the comparator, and determine the recommended dose.

Timeline

Start
2023-03-22
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Valsartan Small molecule Oral
Subject sitokiren Small molecule 50 mg Oral
Subject sitokiren Small molecule 100 mg Oral
Subject sitokiren Small molecule 200 mg Oral