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

NCT06660940 | Not Yet Recruiting Phase 4

• 1 other identifier: BOJI2022080XY
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Kidney Disease; Diabetic Retinopathy

Keywords

Diabetic kidney disease; Keluoxin Capsules; Diabetic retinopathy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline,52 weeks

Secondary Outcomes (8)

• The urine albumin creatine ratio (UACR) level and changes from baseline at each visit.

  baseline, 8, 16, 28, 40, and 52 weeks

• The eGFR level and changes from baseline at each visit.

  baseline, 8, 16, 28, 40, and 52 weeks

• The ophthalmic indicators level and changes from baseline at each visit.

  baseline, 8, 16, 28, 40, and 52 weeks

• The Chinese medicine syndrome scores and changes from baseline at each visit.

  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.

  baseline, 8, 16, 28, 40, and 52 weeks

Study Arms (2)

Keluoxin Capsules

EXPERIMENTAL

Patients will take Keluoxin Capsules and renin-angiotensin-aldosterone system inhibitors (RAASIs).

Drug: Keluoxin Capsules; Drug: Irbesartan

Placebo

PLACEBO COMPARATOR

Patients will take placebo and RAASIs.

Drug: Keluoxin Capsule Simulants; Drug: Irbesartan

Interventions

Keluoxin Capsules DRUG

Treatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day

Keluoxin Capsules

Keluoxin Capsule Simulants DRUG

Treatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day

Placebo

Irbesartan DRUG

1. Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD; 2. Treatment period (52 weeks): Irbesartan 75-300mg/d, QD

Keluoxin Capsules; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old, either sex;
• Meeting the diagnostic criteria for type 2 diabetes mellitus and DKD;
• The target eye met the diagnostic criteria for type 2 DR and the fundus showed moderate or severe NPDR;
• Have been treated with an adequate dose of RAASIs for more than 4 weeks;
• The 24h UTP between 0.5g and 3.5g (results of two tests);
• The eGFR ≥30ml/min/1.73m2；
• Blood pressure (BP) ≤ 140/90mmHg;
• Hemoglobin A1c (HbA1c) \< 9%;
• Voluntarily sign the informed consent form.

You may not qualify if:

• Patients with a known or suspected history of allergy to the test drug and its excipients;
• Various primary kidney diseases or non-diabetic kidney disease as judged by the investigator;
• Heat-toxin syndrome: swelling and pain the throat , redness, swelling, and pain in the eyes, mouth and tongue sores, swollen and painful gums, cough with yellow phlegm, stool stem nod, deep colored urine, red tongue with yellow coating; cold-dampness syndrome: poor appetite, borborygmus, diarrhoea, drowsiness, clear urine in large amounts and high frequency, menstrual disorders, aversion to cold and cold limbs; meet the either manifestation of heat-toxin syndrome or cold-dampness syndrome, that is, the need to be excluded;
• The patient's eye has any of the following conditions:
• Received periocular corticosteroid injections within 3 months prior to screening;
• Use of Chinese patent medicines or chemical drugs with therapeutic effects on DR (e.g., Calcium Dobesilate, Difrarel, Qiming Granules, Shuangdan Mingmu Capsules) within 2 weeks prior to screening;
• Suffering from other retinal diseases affecting the macula, e.g. central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), wet age-related macular degeneration (AMD), choroidal neovascularization (CNV), CI-DME, ocular ischemic syndrome, Irvine-Gass syndrome, radiation retinopathy;
• Suffering from other eye diseases that affect vision, such as glaucoma, uveitis, optic neuropathy, retinal detachment;
• Have undergone the following ophthalmic surgeries or treatments: vitrectomy, macular buckling, glaucoma filtration surgery, panretinal photocoagulation, macular photocoagulation, photodynamic therapy, optic neurotomy, optic nerve sheath fenestration, etc;
• Undergone the following eye surgeries within 3 months prior to screening, including cataract surgery and keratoplasty;
• The need for cataract surgery during the study period;
• Presence of refractive medium opacity and/or pupillary abnormality that affect fundus photography and OCTA imaging; 2. Either eye:
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• Received intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs or corticosteroids within 3 months prior to screening;
• Suffering from active inflammation of the eye or periocular area (e.g., hordeolum, infectious conjunctivitis, keratitis, scleritis, endophthalmitis);

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetic Retinopathy

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Xiangmei chen

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangmei Chen

CONTACT

00-86-010-66937166; liping.8@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 28, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share