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

Primary Purpose

Diabetic Nephropathies

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CU01-1001
Placebo
Sponsored by
Curacle Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Women who are pregnant or breastfeeding a baby 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 Patients who participated in other clinical study within 12 weeks of the participation in this study Patients who are not eligible for this study participation in the judgment of the principal investigator or sub-investigator

Sites / Locations

  • Yeongnam University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CU01-1001 (low dose)

CU01-1001 (high dose)

Placebo

Arm Description

1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch)

1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner)

1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
February 6, 2023
Sponsor
Curacle Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05718375
Brief Title
Phase IIb Clinical Trial for the Efficacy and Safety by CU01-1001 for 24 Weeks in Type 2 DM Patients With Albuminuria
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curacle Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CU01-1001 (low dose)
Arm Type
Experimental
Arm Description
1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch)
Arm Title
CU01-1001 (high dose)
Arm Type
Experimental
Arm Description
1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner)
Intervention Type
Drug
Intervention Name(s)
CU01-1001
Intervention Description
CU01-1001
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Description
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Time Frame
Day 0, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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 Women who are pregnant or breastfeeding a baby 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 Patients who participated in other clinical study within 12 weeks of the participation in this study Patients who are not eligible for this study participation in the judgment of the principal investigator or sub-investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunjeong Kim
Phone
+82-2-3487-0077
Email
hjkim02@curacle.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KyuChang Won
Organizational Affiliation
Yeongnam University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HyeJin Yoo
Organizational Affiliation
Koera University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Hwa Hong
Organizational Affiliation
Eulji University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Min Cho
Organizational Affiliation
Seoul National University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeongnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyuChang Won
Phone
+82-53-620-3846
First Name & Middle Initial & Last Name & Degree
KyuChang Won

12. IPD Sharing Statement

Plan to Share IPD
No

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

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