Phase IIb Clinical Trial for the Efficacy and Safety by CU01-1001 for 24 Weeks in Type 2 DM Patients With Albuminuria

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Drug: Placebo; Drug: CU01-1001

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hyunjeong Kim; Phone Number: +82-2-3487-0077; Email: hjkim02@curacle.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Yeongnam University Medical Center
    • Contact: KyuChang Won; Phone Number: +82-53-620-3846

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. NYHA class III~IV
3. 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)
4. 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.)
5. Patients with acute disease (including infectious diseases) at screening and who are thought to be unable to participate in the clinical study)
6. 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
7. Patients with history of alcohol or drug abuse
8. Patients with any allergic reaction to the investigational product or its components
9. Patients who are planning to receive dialysis or renal transplantation within 36 weeks (9 months) in the future
10. Patients who are expected to have lower compliance with protein-limited diets and the use of the study drug
11. Women who are pregnant or breastfeeding a baby
12. Women who are able to become pregnant and do not agree to use acceptable contraception as defined by the protocol; however, women of childbearing potential who have not gone sterility procedures can participate in the study only for negative pregnancy test, and should agree to maintain effective contraception (implants of intrauterine device or intrauterine system, double barrier contraception (condom, diaphragm, sponge or cervical cap with spermicide), oral contraceptives, sterilization, and total abstinence) throughout the study
13. Patients who participated in other clinical study within 12 weeks of the participation in this study
14. Patients who are not eligible for this study participation in the judgment of the principal investigator or sub-investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CU01-1001 (low dose); 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch)	Drug: Placebo; Placebo; Drug: CU01-1001; CU01-1001
EXPERIMENTAL: CU01-1001 (high dose); 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner)	Drug: CU01-1001; CU01-1001
PLACEBO_COMPARATOR: Placebo; 1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner)	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline	Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline	Day 0, 24 weeks

Collaborators and Investigators

• Sponsor: Curacle Co., Ltd.
• Investigators: Principal Investigator: KyuChang Won, Yeongnam University Medical Center; Principal Investigator: HyeJin Yoo, Koera University Guro Hospital; Principal Investigator: Jun Hwa Hong, Eulji University Hospital; Principal Investigator: Young Min Cho, Seoul National University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2023
• Primary Completion (ANTICIPATED): September 30, 2024
• Study Completion (ANTICIPATED): September 30, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Urination Disorders; Proteinuria; Kidney Diseases; Diabetic Nephropathies; Albuminuria
• Other Study ID Numbers: CU01-1001-DN-P2b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No