Status:
COMPLETED
Different Vascular and Renal Parameters in Living Kidney Donors
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Renal Injury
Eligibility:
All Genders
30-85 years
Brief Summary
Chronic kidney disease (CKD) has a high prevalence globally and is a global health concern. CKD is associated with increased risks of cardiovascular morbidity, mortality and therefore decreased qualit...
Detailed Description
Chronic kidney disease (CKD) has a high prevalence globally and is a global health concern. KDIGO-Guidelines describes CKD as an abnormality of kidney function or structure, present more than 3 months...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06056466
Start Date
May 8 2019
End Date
February 15 2024
Last Update
August 14 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, Germany, 91054