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To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CU01-1001 (low dose) | Experimental | 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch) |
|
| CU01-1001 (high dose) | Experimental | 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner) |
|
| Placebo | Placebo Comparator | 1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CU01-1001 | Drug | CU01-1001 |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a history of acute kidney injury (AKI) within 12 weeks prior to screening, or with an increase in serum creatinine (SCr) ≥ 0.3 mg/dL within 48 hours, or an increase to ≥ 1.5 times the baseline (lowest value within the prior 12 weeks)
Patients with a history or current diagnosis of heart failure classified as New York Heart Association (NYHA) Class III or IV, or a history of hospitalization due to heart failure
Patients with renal disease, including but not limited to:
Patients with a history of hepatic disease or meeting any of the following criteria related to liver function:
Patients with a white blood cell (WBC) count < 2 × 10³/µL
Patients with a lymphocyte count < 0.5 × 10⁹/L
Patients with hemoglobin < 9 g/dL
Patients with organic gastrointestinal disorders or chronic gastrointestinal diseases associated with clinically significant malabsorption at screening, including but not limited to:
Patients with a clinically significant infection requiring treatment at the time of screening
Patients who, within 12 weeks prior to informed consent, have been diagnosed with or undergone treatment/procedures for the following cardiovascular conditions:
Patients who have received any of the following prohibited concomitant medications within 4 weeks or within 5 half-lives (whichever is longer) prior to screening:
(1) Fumaric acid derivatives other than the investigational product (2) Diuretics, including:
Female subjects of childbearing potential who have not undergone surgical sterilization must have a negative pregnancy test prior to participation and must agree to use highly effective contraception throughout the study period 18) Patients who have participated in another clinical trial within 12 weeks prior to screening 19) Patients who are deemed unsuitable for participation in this clinical trial at the discretion of the investigator or sub-investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | ||||
| SoonChunHyang University Hospital Cheonan |
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| Placebo |
| Drug |
Placebo |
|
| Chuncheon |
| South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Hospital | Daegu | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | South Korea |
| Yeongnam University Medical Center | Daegu | South Korea |
| Daejeon Eulji Medical Center, Eulji University | Daejeon | South Korea |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Gyeonggi-do | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| The Catholic University of Korea Bucheon St. Mary's Hospital | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Jeonbuk National University Hospital | Jeonju | South Korea |
| Hallym University Gangnam Sacred Heart Hospital | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Hospital | Seoul | South Korea |
| Nowon Eulji University | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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