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

Sponsor
Chinese PLA General Hospital
Study ID
NCT06660940
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 28, 2024
Start date
Oct 31, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Keluoxin Capsules
    Patients will take Keluoxin Capsules and renin-angiotensin-aldosterone system inhibitors (RAASIs).
  • Placebo Comparator: Placebo
    Patients will take placebo and RAASIs.

Primary Outcome Measure

The 24-hour urinary protein quantitation (24h UTP) level and changes from baseline at 52 weeks. [ Time Frame: baseline,52 weeks ]

Central Contacts

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