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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT05286632
Eligibility Criteria:
Inclusion Criteria:
\- Age
1. Participant must be ≥18 years of age, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2. Participants with Chronic Kidney Disease (CKD) classified as Glomerular Filtration Rate (GFR) category G3b (30-44 ml/min/1.73 m2) or G4 (15-29 ml/min/1.73 m2); persistent albuminuria category A1 (\<30 mg/g \[\<3 mg/mmol\]) or A2 (30-300 mg/g \[3-30 mg/mmol\]); AND with presence of at least of the following causal etiologies: diabetes, arterial hypertension, chronic glomerulonephritis, cystic kidney diseases (e.g. polycystic kidney, nephronophthisis, cortical or tubular glomerular cysts, cystic diseases of the renal medulla, tuberous sclerosis, etc); AND with both abnormalities of kidney function (i.e., GFR and albuminuria) and structure (causal etiologies) present for \>3 months, with implications for health.
AND with a total score \>12 in the Perceived Stress Scale (PSS) questionnaire by Cohen (Appendix E).
Sex
3. Male and Female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Informed Consent
4. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
\- Other Criteria
5. Participants owning a mobile phone, willing to use mobile Apps and this type of technology (technology-savvy) and to download KidneYou.
6. Native speakers of Italian language or foreign subjects who have a full understanding of the Italian language, as the instructions and information for all health programs (i.e., dietary, physical activity, mindfulness) will only be given in Italian.
Exclusion Criteria:
\- Medical Conditions
1. Any type of acute and/or chronic joint disease that prevents the patient from undergoing the recommended physical activities and interferes with the performance of the 6-MWT.
2. Any type of acute and/or chronic muscle diseases.
3. History or current evidence of depression, sleep disturbance, suicidal ideation or any mental (behavioural or psychological illness) disorder.
4. Patient's refusal or inability to follow dietary rules due to socio-economic or psychological distress.
5. Chewing disorder.
6. Lack of motivation to follow NP, PA program, psychological program and/or deterioration in the quality of life.
7. Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, Child-Pugh class C (Appendix G), at baseline visit.
8. Evidence to have tested positive for human immunodeficiency virus (HIV).
9. History or current evidence of drug or alcohol abuse.
10. History of QT prolongation and/or congenital long QT syndrome.
11. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
12. Solid cancer, blood and/or hematopoietic cancer
13. Autoimmune diseases (i.e. systemic lupus erythematosus, scleroderma, rheumatoid arthritis, etc.).
14. Addison's disease.
15. Amyloidosis.
\- Prior/Concomitant Therapy
16. Any change (e.g., increase/decrease of medication dosage(s), termination of current medication(s), addition of new medication(s), replacement of one or more medication(s)) in the current patient's treatment strategy (concomitant therapies) due to subject's enrolment in this study.
\- Prior/Concurrent Clinical Study Experience
17. Participation in another clinical study with an Investigational Product administered in the last 6 months.
\- Diagnostic Assessments
18. Not applicable.
\- Other Exclusions
19. Involvement in the planning and/or conduct of the study (applies to both Advice Pharma S.r.l. staff and/or staff at the study site).
20. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
21. Previous enrolment or randomisation in the present study.
22. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
23. As judged by the investigator, any evidence of CKD patient's condition which in the investigator's opinion makes it undesirable for the subject to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05286632
Study Brief:
Protocol Section:
NCT05286632