Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06866158
Eligibility Criteria:
Inclusion Criteria:
1. Male or female over 18 years old
2. Understands and agrees to comply with study procedures by providing written informed consent.
3. In the investigator's judgment, the subject is able and willing to comply with study procedures.
4. In the investigator's judgment, the subject is in generally good physical and mental health. This includes the following factors:
* Age \> 65 years
* Mild to moderate obesity (BMI 30 to 40)
* Controlled hypertension with medication
* Controlled hyperlipidemia with medication
* Mild chronic lung disease
* Previously diagnosed with cancer and in remission for at least 1 year
5. Meets the diagnostic criteria for Type 2 Diabetes Mellitus (DM) according to Indonesia's Endocrinology Society (PERKENI) 2021.
6. eGFR ≥ 30 mL/min/1.73 m².
7. Urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g.
Exclusion Criteria:
1. Receiving immunosuppressive treatments such as corticosteroids, hydroxychloroquine, methotrexate, cyclophosphamide, and others within the last 4 weeks.
2. Known to have other kidney diseases (e.g., polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.).
3. Known to have other conditions that can cause albuminuria (e.g., myeloma, rhabdomyolysis, paroxysmal nocturnal hemoglobinuria, orthostatic albuminuria, etc.).
4. Diagnosed with other types of diabetes (Type 1 DM, gestational DM, or other forms of DM).
5. Positive pregnancy test.
6. Known to have immunodeficiency diseases such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); no blood testing required.
7. Requires oxygen supplementation.
8. Diagnosed with invasive cancer and currently receiving anti-cancer therapy, except for hormonal therapy for breast or prostate cancer.
9. History of thromboembolism or a genetic predisposition to thromboembolism, or currently on anti-thromboembolic therapy other than low-dose aspirin.
10. Physical or mental disabilities preventing normal daily activities.
11. In the investigator's judgment, any illness or medical condition that may hinder the subject's participation, including acute, subacute, intermittent, or chronic diseases that could place the subject at risk of injury, prevent compliance with the study protocol, or interfere with study assessments.
12. Measurable parameters include:
* Severe obesity: BMI \> 40
* Uncontrolled hypertension: systolic \>180 mmHg, diastolic \>100 mmHg
13. Unwilling to sign the written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06866158
Study Brief:
Protocol Section:
NCT06866158