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New drug shows promise for diabetic kidney damage in Mid-Stage trial

NCT ID NCT05718375

Disease control Sponsor: Curacle Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called CU01-1001 in 240 adults with type 2 diabetes and early kidney damage (albuminuria). Participants took the drug or a placebo for 24 weeks to see if it could reduce protein leakage in urine, a sign of kidney health. The goal is to find a treatment that helps control diabetic kidney disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

240 people

The number who actually took part.

Started

Feb 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male/female patients aged ≥ 30 years 2. Patients diagnosed with type 2 diabetes prior to screening 3. 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 4. 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 5. Patients with blood pressure ≤ 140/90mmHg at screening 6. Patients with 25 ≤ estimated glomerular filtration rate (eGFR) ≤ 75ml/min/1.73m2 at screening 7. Patients with HbA1c ≤ 9.0% at screening Exclusion Criteria: 1. 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) 2. 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 3. Patients with renal disease, including but not limited to: * Non-diabetic kidney disease * Urological disorders * Nephrotic syndrome 4. 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 5. Patients with a white blood cell (WBC) count \< 2 × 10³/µL 6. Patients with a lymphocyte count \< 0.5 × 10⁹/L 7. Patients with hemoglobin \< 9 g/dL 8. 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 9. Patients with a clinically significant infection requiring treatment at the time of screening 10. 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) 11. 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: * 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

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic nephropathies

Contacts and locations

Locations

  • Ajou University Hospital

    Gyeonggi-do, South Korea

  • Daegu Catholic University Medical Center

    Daegu, South Korea

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, South Korea

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    Gyeonggi-do, South Korea

  • Hallym University Gangnam Sacred Heart Hospital

    Seoul, South Korea

  • Jeonbuk National University Hospital

    Jeonju, South Korea

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Korea University Ansan Hospital

    Gyeonggi-do, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kyung Hee University Hospital

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • Nowon Eulji University

    Seoul, South Korea

  • Pusan National University Hospital

    Busan, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital

    Seoul, South Korea

  • SoonChunHyang University Hospital Cheonan

    Chuncheon, South Korea

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    Gyeonggi-do, South Korea

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, South Korea

  • Yeongnam University Medical Center

    Daegu, South Korea

More trials for these conditions

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