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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04243850
Eligibility Criteria:
Inclusion Criteria:
* Caucasian\*
* Both genders (females must be post-menopausal; no menses \>1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as \>31 U/L)
* Age: 45 - 80 years
* BMI: \>25 kg/m2
* For with people with diabetes - a diagnosis of T2DM with glycosylated haemoglobin (HbA1c) ≥6.5% (≥48 mmol/mol) and \<10.5% (\<91 mmol/mol); and eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 or \>75 mL/min/1.73m2 at the Screening Visit (Visit 1).
* In the normoglycemic, hypertensive, individuals: HbA1c \<6.5% (\<48 mmol/mol) and an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit (Visit 1).
* In the diabetic arm: people with an eGFR \>75 ml/min/1.73m2 should be treated with a stable dose of metformin and/or SU, people with an eGFR between ≥25 and ≤50 mL/min/1.73m2 should be treated with a stable dose of metformin, SU and/or insulin therapy for at least 3 months prior to inclusion
* Patient specific antihypertensive dose of an angiotensin receptor blocker (ARB) (as per Investigator's judgement) for at least 4 weeks prior to Visit 2 (Day 3).
* Written informed consent
Exclusion Criteria:
* History of unstable or rapidly progressing renal disease
* Macroalbuminuria; defined as ACR of 300mg/g.
* Diagnosis of polycystic kidney disease.
* Post renal transplant
* History of or current lupus nephritis.
* Abnormal vital signs, after 10 minutes supine rest, definas as any of the following (Visit 1):
* Systolic blood pressure above 180 mmHg
* Diastolic blood pressure above 110 mmHg
* Current/chronic use of the following medication: SGLT2 inhibitors,TZD, GLP-1RA, DPP-4 inhibitors, , antimicrobial agents or chemotherapeutics.
* Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drug can be taken within a time-frame of 2 weeks prior to renal-testing
* History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
* Current urinary tract infection and active nephritis
* Recent (\<3 months) history of cardiovascular disease, including:
* Acute coronary syndrome
* Chronic heart failure (New York Heart Association grade II-IV)
* Stroke or transient ischemic neurologic disorder
* Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
* Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
* History of or actual malignancy (except basal cell carcinoma)
* History of or actual severe mental disease
* Substance abuse (alcohol: defined as \>4 units/day)
* Allergy to any of the agents used in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT04243850
Study Brief:
Protocol Section:
NCT04243850