Diabetic NephropathiesPhase 2NCT05718375
Phase IIb Clinical Trial for the Efficacy and Safety by CU01-1001 for 24 Weeks in Type 2 DM Patients With Albuminuria
A Phase 2 study testing CU01-1001 in people with Diabetic Nephropathies, run by Curacle Co., Ltd. at 24 sites in South Korea.
Trial summary
To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- CU01-1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 24 sitesSouth Korea
- Study dates
- 14 Feb 2023to 12 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- Non-diabetic kidney disease
- Urological disorders
- Nephrotic syndrome
Show all 30Show fewer
- Patients with a history of hepatic disease or meeting any of the following criteria related to liver function:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN)
- Total bilirubin > 3 × ULN
- 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:
- Short bowel syndrome
- Active Crohn's disease
- Ulcerative colitis
- 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:
- Unstable angina pectoris
- Myocardial infarction
- Transient ischemic attack (TIA)
- Cerebrovascular accident (stroke)
- Peripheral vascular disease, or
- Have undergone coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA)
- 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:
- Fumaric acid derivatives other than the investigational product (2) Diuretics, including:
- Thiazide (e.g., hydrochlorothiazide)
- Loop (e.g., furosemide)
- Potassium-sparing agents (e.g., spironolactone) (3) Lipid-lowering agents, including fibrates and nicotinic acid (4) Interferon beta-1α, anticancer agents, immunosuppressants, live vaccines, or nephrotoxic drugs (e.g., aminoglycosides, NSAIDs excluding acetylsalicylic acid, lithium) (5) Any other medications that, in the opinion of the investigator, may affect the investigational product 12) Patients with a history of alcohol or substance abuse 13) Patients with a known hypersensitivity to the investigational product or any of its components 14) Patients with a planned initiation of dialysis or kidney transplantation within 36 weeks (9 months) 15) Patients who are anticipated to have poor compliance with a protein-restricted diet and administration of the investigational product 16) Pregnant or breastfeeding women 17) Patients of childbearing potential who are unwilling to agree to the use of acceptable methods of contraception as specified in this protocol, and therefore are at risk of pregnancy.
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
South Korea24 sites
Pusan National University Hospital
Busan
SoonChunHyang University Hospital Cheonan
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Hospital
Daegu
Kyungpook National University Chilgok Hospital
Daegu
Yeongnam University Medical Center
Daegu
Daejeon Eulji Medical Center, Eulji University
Daejeon
Ajou University Hospital
Gyeonggi-do
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
Seoul National University Bundang Hospital
Gyeonggi-do
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Jeonbuk National University Hospital
Jeonju
Hallym University Gangnam Sacred Heart Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Hospital
Seoul
Nowon Eulji University
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
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
To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria.
- Conditions
- Diabetic Nephropathies
- Being tested
- CU01-1001, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU01-1001Drug
CU01-1001
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CU01-1001 (low dose) | Experimental | 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch) Receives: Drug: CU01-1001; Drug: Placebo |
| CU01-1001 (high dose) | Experimental | 1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner) Receives: Drug: CU01-1001 |
| Placebo | Placebo comparator | 1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Feb 2023
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curacle Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718375
- Sponsor's protocol ID
- CU01-1001-DN-P2b
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05718375
- Acronym / sponsor ID
- CU01-1001-DN-P2b
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Curacle Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CU01-1001 (low dose) | Experimental | Drug: CU01-1001, Drug: Placebo1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch) |
| CU01-1001 (high dose) | Experimental | Drug: CU01-10011 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner) |
| Placebo | Placebo comparator | Drug: Placebo1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CU01-1001CU01-1001 | Drug | CU01-1001 (high dose), CU01-1001 (low dose) |
| PlaceboPlacebo | Drug | CU01-1001 (low dose), Placebo |
Primary outcome
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Time frame: Day 0, 24 weeks
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CU01-1001 in people with Diabetic Nephropathies, run by Curacle Co., Ltd. at 24 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline (time frame: Day 0, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.