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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT06056466
Eligibility Criteria:
Inclusion Criteria:
* Age of 30 - 85 years
* Male and Female patients
* Persons (evaluated and accepted for kidney donation) in good and stable health condition with eGFR\>60 ml/min/1.73m²
* Informed consent has to be given in written form
Exclusion Criteria:
* Type-2-diabetes or any other form of diabetes (fasting plasma glucose ≥ 126 mg/dl, HbA1c ≥ 6,5%, post prandial glucose ≥ 200 mg/dl \*
* Uncontrolled arterial hypertension (≥ 180/110 mmHg) \*
* Any history of stroke, transient ischemic attack, instable angina pectoris or myocardial infarction within the last 6 months prior to study inclusion \*
* Estimated glomerular filtration rate ≤ 60 ml/min/1.73m² \*
* Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 times above the upper limit of normal range \*
* Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial \*
* Patients suffering from cataract or glaucoma +
* Diabetic retinopathy \*
* active Drug or alcohol abuse \*
* Pregnant and breast-feeding patients \*
* Body mass index \> 33 kg/m² \*
* Participation in another clinical study within 30 days prior to visit 1+
* Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V +
For patients undergoing 23Na- and ASL-MRI:
* Implanted pacemakers or defibrillators +
* Other implanted metallic devices, which are not MRI compatible +
* Claustrophobia +
* Any other relevant clinical contraindication of MRI examination +
* Please note that these exclusion criteria are also exclusion criteria of our kidney donation programme + These exclusions are due to the study, in particular due to methods we apply at visit 2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT06056466
Study Brief:
Protocol Section:
NCT06056466