NCT06660940

Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy

A Randomized, Double-blind, Multicenter Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of Keluoxin Capsules for the treatment of diabetic kidney disease (DKD) and diabetic retinopathy (DR) compared to placebo on a conventional treatment basis.

Detailed description

DKD and DR are the main microvascular complications of diabetes mellitus. DKD is currently the leading cause of end-stage renal disease (ESRD), while DR is the leading cause of blindness in the working age population. DKD and DR have similar pathogenesis and pathological manifestations. For patients with DKD whose estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m2, the proportion of patients with mild, moderate and severe non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) was 17.38%, 27.57%, 12.29% and 2.28%, respectively. The previous research results showed that Keluoxin Capsules could improve DKD symptoms, reduce proteinuria, protect renal function, and stabilize or improve DR. This study is a multicenter,double-blind, randomized controlled trial. We plan to enroll 460 participants, who will be randomized to receive either Keluoxin capsules(230 cases) or placebo(230 cases) on a conventional treatment basis for 52 weeks.

Conditions

• Diabetic Kidney Disease
• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Keluoxin Capsules	Treatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day
DRUG	Keluoxin Capsule Simulants	Treatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day
DRUG	Irbesartan	1. Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD; 2. Treatment period (52 weeks): Irbesartan 75-300mg/d, QD

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-10-28
• Last updated: 2024-10-28