Diabetic Kidney DiseaseNCT06686758
Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients
A study testing Sugar cane polysaccharide in people with Diabetic Kidney Disease, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The purpose of this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Sugar cane polysaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to May 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.
- HbA1c ≤9% at screening.
- Elevated albuminuria defined as either: uACR ≥30 mg/g on ≥2 occasions within 3 months or sustained proteinuria >300 mg/24-hour urine collection.
- eGFR ≥60 mL/min/1.73 m² (CKD-EPI equation) at baseline.
- Stable RAS blockade therapy meeting either: Maximum tolerated dose of ACE inhibitor/ARB for ≥4 weeks pre-screening or documented intolerance to ACEi/ARB (with nephrologist confirmation).
- If using SGLT2 inhibitors and/or nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs): stable regimen ≥4 weeks pre-enrollment or commitment to maintain dosing throughout study.
- Capacity to provide written informed consent (self or via legally authorized representative).
Who cannot join
- Type 1 diabetes or secondary diabetes.
- Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.
- Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).
- Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).
- patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.
- patients with a history of malignancy within 5 years.
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- participation in other clinical studies within 3 months.
- Pregnant or lactating women.
- hypersensitivity to any of the components of the interventions in this study.
- alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Trial Investigating the Efficacy and Safety of LC-Z300-01 on Proteinuria in Patients With Diabetic Kidney Disease
The purpose of this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD).
Read the detailed description
The incidence of diabetic nephropathy has shown a year-by-year increase, establishing it as the leading cause of uremia. Despite guideline-recommended therapies such as RAS inhibitors, patients with diabetic nephropathy continue to face elevated risks of disease progression, particularly when massive proteinuria persists. Early intervention through nephropathy management can effectively slow renal function deterioration, demonstrating substantial clinical value in mitigating uremia risk.
LC-Z300-01, a sugarcane-derived polysaccharide formulated as a dietary supplement, is being evaluated in this prospective, placebo-controlled, double-blind, randomized clinical trial. Sixty participants with confirmed diabetic nephropathy will be randomly allocated (1:1:1) to receive low-dose polysaccharide, high-dose polysaccharide, or placebo for 24 weeks of intervention and subsequent monitoring.
The predefined primary endpoint is the absolute change in uACR from baseline to week 24. Secondary endpoints encompass: (1) proportion of participants achieving ≥30% reduction in uACR versus baseline; (2) annualized eGFR decline rate; (3) HbA1c trajectory alterations; and (4) time-in-range (TIR) glycemic control metrics. Safety assessments will be conducted for all enrolled subjects receiving ≥1 administered dose.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Sugar cane polysaccharide, Control
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar cane polysaccharideDietary supplement
Sugar cane polysaccharide
ControlDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| low-dose LC-Z300-01 | Experimental | Sugar cane polysaccharide LC-Z300-01: 0.5g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. Receives: Dietary Supplement: Sugar cane polysaccharide |
| high-dose LC-Z300-01 | Experimental | Sugar cane polysaccharide LC-Z300-01: 1.0g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. Receives: Dietary Supplement: Sugar cane polysaccharide |
| control | Placebo comparator | Identical placebo: 2 tablets, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in patient uACR compared to baseline
Events based on uACR measure compared to baseline
Measured: 24 weeks
Secondary outcomes (5)
Estimated Glomerular Filtration Rate (eGFR) slope
Based on eGFR ( by CKD-EPI formula ) slope
Measured: 24 weeks
Change from baseline in HbA1c
Based on instrumental measurements of HbA1c
Measured: 24 weeks
Change from baseline in glucose time in target range
Based on continuous glucose monitoring
Measured: 24 weeks
The proportion of patients with uACR ≥30% lower than baseline
Based on UACR measure compared to baseline
Measured: 24 weeks
Incidence of adverse reactions
The proportion of patients with adverse reactions to the total population
Measured: Start of treatment until the end of the treatment for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study startApr 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (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 Shanghai Changzheng 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686758
- Sponsor's protocol ID
- 2024SL109
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Efficacy and Safety of LC-Z300-01 on Proteinuria in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06686758
- Acronym / sponsor ID
- 2024SL109
- Conditions
- Diabetic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Nov 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 this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD).
Detailed description
The incidence of diabetic nephropathy has shown a year-by-year increase, establishing it as the leading cause of uremia. Despite guideline-recommended therapies such as RAS inhibitors, patients with diabetic nephropathy continue to face elevated risks of disease progression, particularly when massive proteinuria persists. Early intervention through nephropathy management can effectively slow renal function deterioration, demonstrating substantial clinical value in mitigating uremia risk.
LC-Z300-01, a sugarcane-derived polysaccharide formulated as a dietary supplement, is being evaluated in this prospective, placebo-controlled, double-blind, randomized clinical trial. Sixty participants with confirmed diabetic nephropathy will be randomly allocated (1:1:1) to receive low-dose polysaccharide, high-dose polysaccharide, or placebo for 24 weeks of intervention and subsequent monitoring.
The predefined primary endpoint is the absolute change in uACR from baseline to week 24. Secondary endpoints encompass: (1) proportion of participants achieving ≥30% reduction in uACR versus baseline; (2) annualized eGFR decline rate; (3) HbA1c trajectory alterations; and (4) time-in-range (TIR) glycemic control metrics. Safety assessments will be conducted for all enrolled subjects receiving ≥1 administered dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose LC-Z300-01 | Experimental | Dietary Supplement: Sugar cane polysaccharideSugar cane polysaccharide LC-Z300-01: 0.5g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. |
| high-dose LC-Z300-01 | Experimental | Dietary Supplement: Sugar cane polysaccharideSugar cane polysaccharide LC-Z300-01: 1.0g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. |
| control | Placebo comparator | Dietary Supplement: ControlIdentical placebo: 2 tablets, 2 times a day , 30 minutes before breakfast and dinner, Oral administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.
- HbA1c ≤9% at screening.
- Elevated albuminuria defined as either: uACR ≥30 mg/g on ≥2 occasions within 3 months or sustained proteinuria >300 mg/24-hour urine collection.
- eGFR ≥60 mL/min/1.73 m² (CKD-EPI equation) at baseline.
Key exclusion criteria (10 listed)
- Type 1 diabetes or secondary diabetes.
- Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.
- Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).
- Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).
- patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.
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 |
|---|---|---|
| Sugar cane polysaccharideSugar cane polysaccharide | Dietary supplement | high-dose LC-Z300-01, low-dose LC-Z300-01 |
| Controlplacebo | Dietary supplement | control |
Primary outcome
Rate of change in patient uACR compared to baseline
Time frame: 24 weeks
Events based on uACR measure compared to baseline
5 secondary outcomes
Estimated Glomerular Filtration Rate (eGFR) slope
Time frame: 24 weeks
Change from baseline in HbA1c
Time frame: 24 weeks
Change from baseline in glucose time in target range
Time frame: 24 weeks
The proportion of patients with uACR ≥30% lower than baseline
Time frame: 24 weeks
Incidence of adverse reactions
Time frame: Start of treatment until the end of the treatment for 12 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 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar cane polysaccharide in people with Diabetic Kidney Disease, run by Shanghai Changzheng Hospital at 1 site in China.
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 8 inclusion and 10 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Lin Li, Dr. (+8613816275180, lilin_616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in patient uACR compared to baseline (time frame: 24 weeks). 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 2 Apr 2025.