CompletedPhase 2

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

South Korea240 participantsStarted 2023-02-14

Plain-language summary

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

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male/female patients aged ≥ 30 years
✓. Patients diagnosed with type 2 diabetes prior to screening
✓. Patients who have been receiving a stable dose of either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening
✓. Patients who experienced albuminuria defined as a urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g within 52 weeks prior to screening, and with UACR between 100 and 1000 mg/g at the time of screening
✓. Patients with blood pressure ≤ 140/90mmHg at screening
✓. Patients with 25 ≤ estimated glomerular filtration rate (eGFR) ≤ 75ml/min/1.73m2 at screening
✓. Patients with HbA1c ≤ 9.0% at screening

✕. 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:

Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline

Timeframe: Day 0, 24 weeks

NCT IDNCT05718375

SponsorCuracle Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-12

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male/female patients aged ≥ 30 years
✓. Patients diagnosed with type 2 diabetes prior to screening
✓. Patients who have been receiving a stable dose of either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening
✓. Patients who experienced albuminuria defined as a urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g within 52 weeks prior to screening, and with UACR between 100 and 1000 mg/g at the time of screening
✓. Patients with blood pressure ≤ 140/90mmHg at screening
✓. Patients with 25 ≤ estimated glomerular filtration rate (eGFR) ≤ 75ml/min/1.73m2 at screening
✓. Patients with HbA1c ≤ 9.0% at screening

✕. 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: