Diabetic Kidney DiseasePhase 4NCT06660940
Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy
A Phase 4 study testing Keluoxin Capsules, Keluoxin Capsule Simulants and Irbesartan in people with Diabetic Kidney Disease and Diabetic Retinopathy, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease, Diabetic Retinopathy
- What is being tested?
- Keluoxin Capsules, Keluoxin Capsule Simulants and Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- Blood pressure (BP) ≤ 140/90mmHg;
- Hemoglobin A1c (HbA1c) < 9%;
- Voluntarily sign the informed consent form.
Who cannot join
- 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:
- 1.Target eye (if both eyes of the patient meet the inclusion criteria, the target eye will be determined by the investigator from a medical point of view. In principle, the eye with more severe lesion will be chosen as the target eye, and the eye with clearer refractive media will be chosen if the lesions are of the same degree):
- Received periocular corticosteroid injections within 3 months prior to screening;
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- 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);
- Suffering from intraocular or intraorbital space-occupying lesions, and malignancy cannot be excluded.
- Have a history of using systemic glucocorticoids and immunosuppressants within 3 months prior to enrolment;
- Experienced active bleeding within 3 months prior to enrolment;
- The eGFR decreased by ≥ 30% within 3 months prior to enrolment;
- Patients with a history of unilateral or bilateral renal artery stenosis;
- BP < 90/60 mmHg;
- Serious acute complications of diabetes mellitus, serious infections within 4 weeks prior to enrolment;
- Serum albumin (ALB) < 30g/L, hemoglobin ≤ 90g/L;
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) reaches more than two times of the upper limit of normal level;
- Comorbid with serious diseases of other organs such as cardiovascular disease, respiratory disease, and other serious diseases that may affect the patient's life;
- Patients with malignancy or malignant diseases that affect the overall prognosis;
- Pregnant and lactating women or women with childbearing plans within 6 months;
- Those who have participated in a clinical trial of another drug within 3 months prior to randomization (referring to those who are randomized and treated with the trial drug);
- Others who were judged by the investigator to be inappropriate for inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Multicenter Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy
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.
Read the detailed description
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.
- Conditions
- Diabetic Kidney Disease, Diabetic Retinopathy
- Being tested
- Keluoxin Capsules, Keluoxin Capsule Simulants, Irbesartan
- Keywords
- Diabetic kidney disease, Keluoxin Capsules, Diabetic retinopathy
- Medical subject headings
- Diabetic Nephropathies, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keluoxin CapsulesDrug
Treatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day
Keluoxin Capsule SimulantsDrug
Treatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day
IrbesartanDrug
- Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD;
- Treatment period (52 weeks): Irbesartan 75-300mg/d, QD
| Study group | Role | What they receive |
|---|---|---|
| Keluoxin Capsules | Experimental | Patients will take Keluoxin Capsules and renin-angiotensin-aldosterone system inhibitors (RAASIs). Receives: Drug: Keluoxin Capsules; Drug: Irbesartan |
| Placebo | Placebo comparator | Patients will take placebo and RAASIs. Receives: Drug: Keluoxin Capsule Simulants; Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline,52 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 8, 16, 28, 40, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- Xiangmei chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660940
- Sponsor's protocol ID
- BOJI2022080XY
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06660940
- Acronym / sponsor ID
- BOJI2022080XY
- Conditions
- Diabetic Kidney Disease, Diabetic Retinopathy
- Keywords
- Diabetic kidney disease, Keluoxin Capsules, Diabetic retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keluoxin Capsules | Experimental | Drug: Keluoxin Capsules, Drug: IrbesartanPatients will take Keluoxin Capsules and renin-angiotensin-aldosterone system inhibitors (RAASIs). |
| Placebo | Placebo comparator | Drug: Keluoxin Capsule Simulants, Drug: IrbesartanPatients will take placebo and RAASIs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (30 listed)
- 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:
- 1.Target eye (if both eyes of the patient meet the inclusion criteria, the target eye will be determined by the investigator from a medical point of view. In principle, the eye with more severe lesion will be chosen as the target eye, and the eye with clearer refractive media will be chosen if the lesions are of the same degree):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keluoxin CapsulesTreatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day | Drug | Keluoxin Capsules |
| Keluoxin Capsule SimulantsTreatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day | Drug | Placebo |
| Irbesartan1. Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD; 2. Treatment period (52 weeks): Irbesartan 75-300mg/d, QD | Drug | Keluoxin Capsules, Placebo |
Primary outcome
The 24-hour urinary protein quantitation (24h UTP) level and changes from baseline at 52 weeks.
Time frame: baseline,52 weeks
Differences between groups using the changes in 24h UTP relative to baseline after 52 weeks treatment.
The macular vascular density or foveal avascular zone area and changes from baseline at 52 weeks.
Time frame: baseline,52 weeks
Differences between groups using the changes in macular vascular density or foveal avascular zone area relative to baseline after 52weeks treatment.
8 secondary outcomes
The urine albumin creatine ratio (UACR) level and changes from baseline at each visit.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The eGFR level and changes from baseline at each visit.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The ophthalmic indicators level and changes from baseline at each visit.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
The Chinese medicine syndrome scores and changes from baseline at each visit.
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.
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
Proportions of patients with serum creatinine doubling
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
Proportions of patients with progressed to ESRD
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
eGFR decline slope
Time frame: baseline, 8, 16, 28, 40, and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangmei chen principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Keluoxin Capsules, Keluoxin Capsule Simulants and Irbesartan in people with Diabetic Kidney Disease and Diabetic Retinopathy, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangmei Chen (00-86-010-66937166, liping.8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 24-hour urinary protein quantitation (24h UTP) level and changes from baseline at 52 weeks. (time frame: baseline,52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.