NCT05593575

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

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Dose-finding Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	SPH3127+SPH3127matching placebo+valsartan matching placebo	1 tablet of SPH3127 (50 mg) ，3 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
DRUG	SPH3127+SPH3127matching placebo+valsartan matching placebo	2 tablet of SPH3127 (50 mg) ，2 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
DRUG	SPH3127+valsartan matching placebo	4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
DRUG	SPH3127 matching placebo+valsartan	4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-25
• Last updated: 2025-02-19

Locations

45 sites across 1 country: China