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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT06841692
Eligibility Criteria:
Inclusion Criteria for CKD subjects:
* CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit
Inclusion Criteria for Healthy subjects:
• eGFR within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function
Exclusion Criteria:
* Known intolerance or allergy to the diuretics
* Current systemic chemotherapy for malignancy
* Kidney transplant recipient
* Use of calcineurin-inhibitors
* Life expectancy \< 12 months
* Current immunosuppressive treatment for glomerulonephritis
* Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
* Hypokalemia or hyperkalemia (K+ \< 3.0mmol/L or K+ \> 5.5 mmol/L) at inclusion visit
* Hypo- or hypernatremia (Na+ \< 130 mmol/L or Na+ \> 150mmol/L) at inclusion visit
* Inherited tubulopathy as the cause of CKD
* Autosomal dominant polycystic or tubulointerstitial kidney disease causing CKD
* Clinically relevant heart failure (New York Heart Association class III or IV)
* Therapy-resistant hypertension, defined as systolic blood pressure \> 180mmHg at the inclusion visit
* Current treatment with inhibitors of Organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide \[22\]
* Active hepatitis during last outpatient visit
* Liver cirrhosis in advanced stage (Child-Pugh B or C)
* Active drug- or alcohol abuse
* Not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing.
* Women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06841692
Study Brief:
Protocol Section:
NCT06841692