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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT04965935
Eligibility Criteria:
Inclusion Criteria:
1. Male or females \>18 years old ≥ 6months after kidney transplantation;
2. In patients with T2D or PTDM, HbA1c \<12.0%;
3. eGFR ≥30 ml/min/1.73m\^2 (as per the CKD-EPI equation);
4. BMI ≤45kg/m\^2;
5. Blood pressure ≤160/90 and ≥90/60 at screening.
Exclusion Criteria:
1. Diagnosis of type 1 diabetes;
2. Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain);
3. Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening;
4. Prior episode of graft pyelonephritis in the 1 month prior to screening;
5. Episode of acute graft rejection in the 3 months prior to screening;
6. Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening;
7. Untreated urinary or genital tract infection;
8. Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness;
9. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;
10. Participation in another trial with an investigational drug within 30 days of informed consent;
11. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation;
12. Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement.
13. Patients currently using antipsychotic medications.
14. Use of SGLT2 inhibitors within 1 month of starting the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04965935
Study Brief:
Protocol Section:
NCT04965935