Health TrialsbyHealthPanel

Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients

ConditionDiabetic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Changzheng Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugar cane polysaccharide

    Dietary supplement

    Sugar cane polysaccharide

  • Control

    Dietary supplement

    placebo

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: low-dose LC-Z300-01Experimental treatment 1 intervention
Group B: high-dose LC-Z300-01Experimental treatment 1 intervention
Group C: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of change in patient uACR compared to baseline

Events based on uACR measure compared to baseline

Time frame
24 weeks

Secondary outcomes

1

Estimated Glomerular Filtration Rate (eGFR) slope

Based on eGFR ( by CKD-EPI formula ) slope

Time frame
24 weeks
2

Change from baseline in HbA1c

Based on instrumental measurements of HbA1c

Time frame
24 weeks
3

Change from baseline in glucose time in target range

Based on continuous glucose monitoring

Time frame
24 weeks
4

The proportion of patients with uACR ≥30% lower than baseline

Based on UACR measure compared to baseline

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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

Shanghai Changzheng Hospital

Lead sponsor

Source ClinicalTrials.gov

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