Health TrialsbyHealthPanel

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

ConditionsDiabetic Kidney DiseaseDiabetic Retinopathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Received periocular corticosteroid injections within 3 months prior to screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Keluoxin CapsulesExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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.)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: