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Keluoxin Capsules for DKD with DR
NCT06660940Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2024
- Primary completion
- Oct 2027
- Sponsor
- Chinese PLA General Hospital
- Modality
- Small Molecules
- Drugs
- Keluoxin
- Conditions
- diabetic kidney disease (DKD)diabetic retinopathy (DR)
01
Overview
Phase 4, randomised, double-blind trial in diabetic kidney disease (DKD) and diabetic retinopathy (DR) comparing Keluoxin Capsules with Placebo (2 arms). Primary endpoints: 24-hour urinary protein quantitation at 52 weeks and Macular vascular density or foveal avascular zone area at 52 weeks. Planned start Oct 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Keluoxin Capsules
Keluoxin Capsules + Irbesartan
Placebo
Placebo + Irbesartan
03
Who it enrols
Adult patients with Type 2 diabetes, DKD, and moderate/severe NPDR, on stable RAASi therapy, with eGFR >= 30 and 24h UTP 0.5-3.5g.
04
Endpoints
Primary
24-hour urinary protein quantitation
Macular vascular density or foveal avascular zone area
Secondary
Urine albumin creatine ratio
Estimated Glomerular Filtration Rate
Ophthalmic indicators level
Chinese medicine syndrome scores
Diabetes quality of life measure
Proportions of patients with serum creatinine doubling
Proportions of patients with progressed to ESRD
eGFR decline slope
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