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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT06794593
Eligibility Criteria:
Patients:
Inclusion criteria:
1. Age ≥ 18 years.
2. A clinical diagnosis of CKD of any course and meet the following criteria at screening:
1. eGFR ≥ 30 ml/min/1.73m2
2. U-ACR ≥ 300 mg/g.
3. Stable antihypertensive treatment 2 weeks before start of investigated medical drug (IMP) and maintain this treatment throughout the study.
4. Office blood pressure at the screening session should be \>120/70 mmHg and \<150/90 mmHg.
5. Capable of providing a signed informed consent and comply with study requirements.
6. Women with childbearing potential must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should use contraception during the study and until one week after completion of study treatment.
Exclusion criteria:
1. Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.
2. Treatment with NSAIDs.
3. Hyperkalemia \> 5.0 mmol/L at screening.
4. P-bilirubin \> 25 umol/L at screening.
5. Ongoing cancer treatment.
6. Treatment with immunosuppressive therapy within 6 months prior to screening.
7. History of organ transplantation.
8. Evidence of current infection (CRP\>50 or temperature \> 38 C°).
9. Severe hepatic insufficiency classified as Child-Pugh C.
10. Breastfeeding.
11. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
12. Recent cardiovascular events \< 2 months prior to screening:
1. Coronary artery revascularization.
2. Acute stroke or TIA.
3. Acute coronary syndrome.
13. Allergy or hypersensitivity to the IMP.
14. Addison's disease.
15. Gastric bypass operation.
16. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.
17. Participation in other clinical trials within the last 30 days.
Healthy controls:
Inclusion criteria:
1. Age ≥ 18 years.
2. Good general health with no significant medical conditions or chronic illness (e.g., diabetes, hypertension, cardiovascular disease, autoimmune diseases, and cancer).
3. Normal kidney function and no proteinuria at screening:
1. eGFR \> 90 ml/min/1.73m2
2. U-ACR \< 30 mg/g
4. Office blood pressure at the screening \< 140/90 mmHg.
5. Capable of providing a signed informed consent and comply with study requirements.
7\. Women with childbearing potential\* must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should use contraception during the study and until one week after completion of study treatment.
Exclusion criteria:
1. Treatment with any prescription medication except oral contraceptives.
2. Use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
3. Hyperkalemia \> 5.0 mmol/L at screening.
4. P-bilirubin \> 25 umol/L at screening.
5. Evidence of current infection (CRP\>50 or temperature \> 38 C°).
6. Breastfeeding.
7. History of substance abuse including alcohol.
8. Allergy or hypersensitivity to the IMP.
9. Gastric bypass operation.
10. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.
11. Participation in other clinical trials within the last 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06794593
Study Brief:
Protocol Section:
NCT06794593