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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
460
Treatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day
Treatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day
1. Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD; 2. Treatment period (52 weeks): Irbesartan 75-300mg/d, QD
The 24-hour urinary protein quantitation (24h UTP) level and changes from baseline at 52 weeks.
Differences between groups using the changes in 24h UTP relative to baseline after 52 weeks treatment.
Time frame: baseline,52 weeks
The macular vascular density or foveal avascular zone area and changes from baseline at 52 weeks.
Differences between groups using the changes in macular vascular density or foveal avascular zone area relative to baseline after 52weeks treatment.
Time frame: baseline,52 weeks
The urine albumin creatine ratio (UACR) level and changes from baseline at each visit.
Differences between groups using the changes in UACR relative to baseline after 8, 16, 28, 40, and 52 weeks treatment.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The eGFR level and changes from baseline at each visit.
Differences between groups using the changes in eGFR relative to baseline after 8, 16, 28, 40, and 52 weeks treatment.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The ophthalmic indicators level and changes from baseline at each visit.
Differences between groups using the changes in ophthalmic indicators (macular perfusion density, foveal avascular zone acircularity index, macular thickness, et al) relative to baseline after 8, 16, 28, 40, and 52 weeks treatment.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The Chinese medicine syndrome scores and changes from baseline at each visit.
Differences between groups using the changes in Chinese medicine syndrome scores relative to baseline after 8, 16, 28, 40, and 52 weeks treatment. (The score of the Chinese medicine syndrome scale ranges from 0 to 24, with higher scores mean a worse outcome.)
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Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The diabetes quality of life measure (DQOL) scale (each domain score) and changes from baseline at each visit.
Differences between groups using the changes in DQOL scale (each dmain score) relative to baseline after 8, 16, 28, 40, and 52 weeks treatment.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
Proportions of patients with serum creatinine doubling
Differences between groups using the proportions of patients with serum creatinine doubling at each visit.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
Proportions of patients with progressed to ESRD
Differences between groups using the proportions of patients with progressed to ESRD at each visit.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
eGFR decline slope
Differences between groups using the eGFR decline slope after 8, 16, 28, 40, and 52 weeks treatment.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks