A Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel Phase IIb Clinical Trial for the Efficacy Assessment and Safety Evaluation by Treating CU01-1001 for 24 Weeks in Type 2 Diabetic Nephropathy Patients With Albuminuria

Curacle Co., Ltd.1 site in 1 country240 target enrollmentJanuary 25, 2023

ConditionsDiabetic Nephropathies

InterventionsCU01-1001 Placebo

DrugsCU01-1001 Placebo

Overview

Phase: Phase 2
Intervention: CU01-1001
Conditions: Diabetic Nephropathies
Sponsor: Curacle Co., Ltd.
Enrollment: 240
Locations: 1
Primary Endpoint: Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria.

Registry

clinicaltrials.gov

Start Date

January 25, 2023

End Date

September 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Curacle Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male/female patients aged 30 years or above
•Patients diagnosed as type 2 diabetes prior to screening
•Patients receiving ACE inhibitors (angiotensin-converting-enzyme inhibitor) or ARB (angiotensin II receptor blockers) for at least 8 weeks prior to screening
•Patients who experienced albuminuria (albumin to creatinine ratio) 200\~1,000 mg/g Cr) at least twice prior to 24weeks including screening results
•Patients with blood pressure ≤ 140/90mmHg at screening
•Patients with 25 ≤ GFR (glomerular filtration rate) ≤ 75ml/min/1.73m2 at screening
•Patients with 6.5% \< HbA1c ≤ 9% at screening

Exclusion Criteria

•Patients with past medical history of acute renal failure within 12weeks prior to screening; or Increase in SCr ≥ 0.3 mg/dL within 48 hours; or an increase in SCr ≥ 1.5-fold from baseline (the lowest value) within 12 weeks; or urine output \<0.5mg/kg/hour for 6 hours
•NYHA class III\~IV
•Patients with medical history related liver disease and hepatic function as follows: ALT (alanine aminotransferase) or AST (aspartate aminotransferase) \>3 X institutional upper limit of normal (ULN), or Total bilirubin \>3 X institutional upper limit of normal (ULN)
•Patients with malabsorption due to organic gastrointestinal disorder or chronic gastroenterological disorders at screening (short-bowel syndrome, active Crohn's disease, and ulcerative colitis, etc.)
•Patients with acute disease (including infectious diseases) at screening and who are thought to be unable to participate in the clinical study)
•Within 12 weeks of the informed consent, patients who had the diagnosis and procedures of the following cardiovascular diseases: cardiac failure (NYHA class III and IV), unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebro-vascular accident, history of peripheral vascular disease or coronary artery bypass surgery, and percutaneous transluminal coronary angioplasty
•Patients with history of alcohol or drug abuse
•Patients with any allergic reaction to the investigational product or its components
•Patients who are planning to receive dialysis or renal transplantation within 36 weeks (9 months) in the future
•Patients who are expected to have lower compliance with protein-limited diets and the use of the study drug